Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
Study NCT ID:
NCT06823466
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-02-02', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASPERA-R Primary Outcome Measure: Baseline demographic characteristics', 'timeFrame': 'At the baseline (index ischemic stroke onset/hospital admission)', 'description': 'Baseline demographic characteristics of ischemic stroke cases occurring on oral anticoagulants: mean age (years), sex (proportion of males and females), ethnicity (proportion of non-Hispanic White, Hispanic White, Black, Asian, other ethnicities), mean weight (Kg), mean height (cm), median BMI'}, {'measure': 'ASPERA-R Primary Outcome Measure: Baseline clinical characteristics', 'timeFrame': 'At the baseline (index ischemic stroke onset/hospital admission)', 'description': 'Baseline clinical characteristics: type of oral anticoagulation at the time of index ischemic stroke (proportion of patients on DOAC or VKA), ischemic stroke clinical severity (median National Insititue of Health Stroke Scale - NIHSS), type of clinical presentation (proportion of patients with anterior or posterior circulation stroke), competing stroke etiology (proportion of patients with large-artery-atherosclerosis or lacunar or other determined or undetermined etiology), risk factors (proportion of patients with hypertension, dyslipidemia, diabetes, history of prior stroke/transient ischemic attack, ischemic cardiopaty, peripheral artery disease, chronic kidney or liver failure), acute ischemic stroke treatment (proportion of patients who undergo intravenous thrombolysis or endovascular thrombectomy)'}, {'measure': 'ASPERA-R Primary Outcome Measure: Baseline Neuroimaging characteristics', 'timeFrame': 'At the baseline (index ischemic stroke onset/hospital admission)', 'description': 'Baseline Neuroimaging characteristics: large vessel occlusion (proportion of patients with large vessel occlusion), site of large vessel occlusion (proportion of patients with anterior or middle or posterior cerebral arteries occlusion), degree of large vessel occlusion (according to the modified treatment in cerebral infarction - mTICI - score: from 0 - no perfusion - to 3 - complete perfusion), median number of new ischemic lesion(s) at neuroimaging, site of new ischemic lesion(s) at neuroimaging (anterior or posterior circulation, right or left hemisphere or bilateral), presence of hemorrhagic infarction at neuroimaging, degree of hemorrhagic infarction at neuroimaging (according to the Heidelberg classification system: Hemorrhagic Infarction - Small petechiae along the margins of the infarcted area or more confluent petechiae without space-occupying effect (HI2). Parenchymal Hematoma - A hematoma covering less (PH1) or more (PH2) than 30% of the infarcted area.'}, {'measure': 'ASPERA-P Primary Outcome Measure: New ischemic stroke or transient ischemic attack', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)'}], 'secondaryOutcomes': [{'measure': 'ASPERA-R Secondary Outcome Measure: All-cause mortality', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'All-cause mortality (proportion of patients who died due to any cause)'}, {'measure': 'ASPERA-R Secondary Outcome Measure: Vascular death', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)'}, {'measure': 'ASPERA-R Secondary Outcome Measure: New ischemic stroke or transient ischemic attack', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'New ischemic stroke or transient ischemic attack (proportion of patients with new ischemic stroke or transient ischemic attack)'}, {'measure': 'ASPERA-R Secondary Outcome Measure: Myocardial infarction', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'Myocardial infarction (proportion of patients with any type of myocardial infarction)'}, {'measure': 'ASPERA-R Secondary Outcome Measure: Moderate-to-severe bleeding events', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'Moderate-to-severe bleeding events (proportion of patients with moderate-to-severe bleedings as defined according to the GUSTO bleeding classification): GUSTO severe or life-threatening bleeding is defined as either intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention. GUSTO moderate bleeding is defined as bleeding requiring transfusion, but not resulting in haemodynamic compromise.'}, {'measure': 'ASPERA-R Secondary Outcome Measure: Intracranial hemorrhage', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'Intracranial hemorrhage (any type of intracranial hemorrhage)'}, {'measure': 'ASPERA-R Secondary Outcome Measure: Ordinal distribution of modified Rankin Scale scores', 'timeFrame': 'Discharge and 90-day post-stroke', 'description': 'Ordinal distribution of modified Rankin Scale scores (proportion of patients within each category of the modified Rankin Scale): Symptoms without any disability (score of 1), Symptoms with mild disability (score of 2), Symptoms with mild-to-moderate disability (score of 3), Symptoms with moderate-to-severe disability (score of 4), Symptoms with severe disability (score of 5), Death (score of 6)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: All-cause mortality', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'All-cause mortality (proportion of patients who died due to any cause)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Vascular death', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Vascular death (death due to stroke, myocardial infarction, pulmonary embolism, sudden death or arrhythmias)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Myocardial infarction', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Myocardial infarction (proportion of patients with any type of myocardial infarction)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Intracranial Hemorrhage', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Intracranial hemorrhage (any type of intracranial hemorrhage)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Moderate-to-severe bleeding events', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Moderate-to-severe bleeding events (proportion of patients with moderate-to-severe bleedings as defined according to the GUSTO bleeding classification): GUSTO severe or life-threatening bleeding is defined as either intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention. GUSTO moderate bleeding is defined as bleeding requiring transfusion, but not resulting in haemodynamic compromise.'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Minor bleeding events', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Minor bleeding events (proportion of patients with minor bleedings as defined according to the GUSTO bleeding classification): Any bleedings that is not intracranial haemorrhage or bleeding resulting in haemodynamic compromise necessitating intervention, or bleeding requiring transfusion.'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Any bleeding events', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Any bleeding events (proportion of patients with any bleedings irrespective of their severity)'}, {'measure': 'ASPERA-P Secondary Outcome Measure: Ordinal modified Rankin Scale scores distribution', 'timeFrame': '90-day, 1-year and 5-year post-stroke', 'description': 'Ordinal distribution of modified Rankin Scale scores (proportion of patients within each category of the modified Rankin Scale): Symptoms without any disability (score of 1), Symptoms with mild disability (score of 2), Symptoms with mild-to-moderate disability (score of 3), Symptoms with moderate-to-severe disability (score of 4), Symptoms with severe disability (score of 5), Death (score of 6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Oral anticoagulation', 'Atrial fibrillation', 'Direct oral anticoagulants', 'Vitamin k antagonists', 'Outcomes', 'Prognosis', 'Clinical characteristics', 'Secondary prevention'], 'conditions': ['Ischemic Stroke', 'Oral Anticoagulation', 'Atrial Fibrillation (AF)', 'Outcome Assessment', 'Clinical Presentations']}, 'descriptionModule': {'briefSummary': "The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval.\n\nASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be enrolled from various recruiting sites worldwide. All consecutive ischemic stroke patients receiving oral anticoagulation therapy for atrial fibrillation or other cardioembolic arrhythmias at the time of the index stroke who meet the inclusion criteria will be eligible, regardless of hospitalization status. The decision to enroll a patient will be made by local investigators, who must ensure that each candidate meets the study's eligibility requirements.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years at the time of the index ischemic stroke.\n* Confirmed diagnosis of ischemic stroke according to the World Health Organization (WHO) definition.\n* Availability of at least one neuroimaging exam (either a non-contrast computed tomography \\[NCCT\\] or magnetic resonance imaging \\[MRI\\] of the brain) demonstrating one or more ischemic lesions consistent with patient symptoms.\n* Ongoing oral anticoagulation at the time of the index ischemic stroke, defined as the last intake within 48 hours prior to stroke symptom onset for patients on direct oral anticoagulants (DOACs), or an international normalized ratio (INR) of ≥1.5 in patients on vitamin K antagonists (VKAs), regardless of the time elapsed between the last intake and stroke symptom onset.\n* Prior diagnosis of AF or other cardioembolic arrhythmias.\n\nExclusion Criteria:\n\n* Symptoms not indicative of acute stroke (i.e., syncope, tonic or clonic activity, dizziness alone, confusion and amnesia alone, chronic or subacute development of focal neurological deficit).\n* Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.'}, 'identificationModule': {'nctId': 'NCT06823466', 'acronym': 'ASPERA', 'briefTitle': 'Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants', 'organization': {'class': 'OTHER', 'fullName': "University of L'Aquila"}, 'officialTitle': 'Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry', 'orgStudyIdInfo': {'id': '2696 - 22/07/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASPERA-R', 'description': 'Retrospectively enrolled schemic stroke patients on oral anticoagulants at the time of the index stroke followed up at hospital discharge and 90 days post-stroke'}, {'label': 'ASPERA-P', 'description': 'Prospectively enrolled ischemic stroke patients on oral anticoagulants at the time of the index stroke followed up at 90 days, 1 year and 5 years post-stroke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Hrvoje Budincevic, MD, PhD', 'role': 'CONTACT', 'email': 'hb@kbsd.hr'}], 'facility': 'Department of Neurology, Sveti Duh University Hospital', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '2400', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Hanne Christensen, MD, DMSci', 'role': 'CONTACT', 'email': 'hanne.krarup.christensen@regionh.dk'}], 'facility': 'Copenhagen University Hospital, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '71526', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Naslreldein, MD', 'role': 'CONTACT', 'email': 'd_ahmednasr@yahoo.com'}], 'facility': 'Neurology Department, Assiut University Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '11566', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Elbassiouny, MD', 'role': 'CONTACT', 'email': 'ahmedelbassiony@gmail.com'}], 'facility': 'Neurology Department, Faculty of Medicine , Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11799', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Elsaid Elsayed, MD, PhD', 'role': 'CONTACT', 'email': 'drahmed5233@gmail.com'}], 'facility': 'Neurology Unit, Kobry Elkoba Medical Complex', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '06001', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Barbara Casolla, MD, PhD', 'role': 'CONTACT', 'email': 'casolla.b@chu-nice.fr'}], 'facility': "Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Nolte, MD, PhD', 'role': 'CONTACT', 'email': 'christian.nolte@charite.de'}], 'facility': 'Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '06112', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Otto, MD, PhD', 'role': 'CONTACT', 'email': 'markus.otto@uk-halle.de'}], 'facility': 'Department of Neurology, Martin-Luther-University of Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '60126', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanna Viticchi, MD', 'role': 'CONTACT', 'email': 'g.viticchi@staff.univpm.it'}], 'facility': 'Neurological Clinic, Marche Polytechnic University', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '70131', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Rinaldi, MD', 'role': 'CONTACT', 'email': 'giuseppe.rinaldi@asl.bari.it'}], 'facility': 'SC Neurologia, Stroke Unit, Ospedale di Venere', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40139', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Guarino, MD', 'role': 'CONTACT', 'email': 'maria.guarino@aosp.bo.it'}], 'facility': 'IRCCS Istituto delle Scienze Neurologiche', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '06012', 'city': 'Città di Castello', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Cenciarelli', 'role': 'CONTACT', 'email': 'silvia.cenciarelli@uslumbria1.it'}], 'facility': 'SCA Neurologia, USL Umbria 1', 'geoPoint': {'lat': 43.46556, 'lon': 12.2375}}, {'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio 44124 Paciaroni, MD', 'role': 'CONTACT', 'email': 'maurizio.paciaroni@unife.it'}], 'facility': "Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna", 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Nencini, MD', 'role': 'CONTACT', 'email': 'nencinip@aou-careggi.toscana.it'}], 'facility': 'SOD Stroke Unit, Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '03100', 'city': 'Frosinone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Rosaria Bagnato, MD', 'role': 'CONTACT', 'email': 'm.rosaria.bagnato@gmail.com'}], 'facility': 'Stroke Unit, Hospital Fabrizio Spazian', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}, {'zip': '67100', 'city': 'L’Aquila', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Sacco, MD', 'role': 'CONTACT', 'email': 'simona.sacco@univaq.it'}], 'facility': "University of L'Aquila", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'zip': '20162', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Cascio Rizzo, MD', 'role': 'CONTACT', 'email': 'angelo.casciorizzo@ospedaleniguarda.it'}], 'facility': 'Neurology and Stroke Unit, ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Candelaresi, MD', 'role': 'CONTACT', 'email': 'paolo.candelaresi@aocardarelli.it'}], 'facility': 'Neurology and Stroke Unit, AORN Antonio Cardarelli', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marina Mannino, MD', 'role': 'CONTACT', 'email': 'marinamannino74@gmail.com'}], 'facility': 'UOC Neurologia e Stroke Unit, AOOR. Villa Sofia - Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43126', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Pezzini, MD', 'role': 'CONTACT', 'email': 'alessandro.pezzini@unipr.it'}], 'facility': 'Department of Medicine and Surgery, University of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Ferrari, MD, PhD', 'role': 'CONTACT', 'email': 'federica.ferrari@mondino.it'}], 'facility': 'Department of Emergency Neurology and Stroke Unit, IRCCS C. Mondino', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '06132', 'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Giulia Mosconi, MD, PhD', 'role': 'CONTACT', 'email': 'mgiulia.mosconi@ospedale.perugia.it'}], 'facility': "Medicina Interna e d'Urgenza - Stroke Unit, Azienda Ospedaliera di Perugia", 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '65124', 'city': 'Pescara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Vittoria De Angelis, MD, PhD', 'role': 'CONTACT', 'email': 'mavidea@yahoo.it'}], 'facility': 'Department of Emergency Neurology and Stroke Unit, Pescara Hospital', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '48124', 'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Pavolucci, MD', 'role': 'CONTACT', 'email': 'lucia.pavolucci@auslromagna.it'}], 'facility': 'Department of Neuroscience, Neurology Unit, S.Maria delle Croci Hospital, AUSL Romagna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42123', 'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Luisa Zedde, MD', 'role': 'CONTACT', 'email': 'marialuisa.zedde@gmail.com'}], 'facility': 'Neurology Unit, Stroke Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00152', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabrina Anticoli, MD', 'role': 'CONTACT', 'email': 'santicoli@scamilloforlanini.rm.it'}], 'facility': 'UOSD Stroke Unit, Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Frisullo, MD, PhD', 'role': 'CONTACT', 'email': 'giovanni.frisullo@policlinicogemelli.it'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '63074', 'city': 'San Benedetto del Tronto', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulio Papiri, MD', 'role': 'CONTACT', 'email': 'giulio.papiri@sanita.marche.it'}], 'facility': 'UOC Neurologia, Ospedale Provinciale "Madonna del Soccorso"', 'geoPoint': {'lat': 42.9568, 'lon': 13.87676}}, {'zip': '53100', 'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rossana Tassi, MD', 'role': 'CONTACT', 'email': 'r.tassi@ao-siena.toscana'}], 'facility': 'UOC Stroke Unit, Emergency and Urgency Department, AOU Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '64100', 'city': 'Teramo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Di Felice, MD', 'role': 'CONTACT', 'email': 'chiaradi.felice@yahoo.com'}], 'facility': 'ASL Abruzzo 4, G.Mazzini Hospital', 'geoPoint': {'lat': 42.66123, 'lon': 13.69901}}, {'zip': '33100', 'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Merlino, MD, PhD', 'role': 'CONTACT', 'email': 'giovanni.merlino@asufc.sanita.fvg.it'}], 'facility': 'SOSD Stroke Unit, Department of Head, Neck, and Neuroscience, Udine University Hospital', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '37126', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Manuel Cappellari, MD', 'role': 'CONTACT', 'email': 'manuel.cappellari@aovr.veneto.it'}], 'facility': 'Stroke Unit, Neurologia A, Azienda Ospedaliera Universitaria Integrata di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '1000', 'city': 'Skopje', 'status': 'RECRUITING', 'country': 'North Macedonia', 'contacts': [{'name': 'Anita Arsovska, MD, PhD', 'role': 'CONTACT', 'email': 'anita70mk@yahoo.com'}], 'facility': 'University Clinic of Neurology, University "Ss.Cyril and Methodius"-Faculty of Medicine', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'zip': '30-688', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Agnieszka Slowik, MD, PhD', 'role': 'CONTACT', 'email': 'agnieszka.slowik@uj.edu.pl'}], 'facility': 'Department of Neurology, Jagiellonian University Medical College', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '1649-028', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Diana Aguiar de Sousa, MD, PhD', 'role': 'CONTACT', 'email': 'dianasousa@campus.ul.pt'}], 'facility': 'Lisbon Central University Hospital - 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J. Safarik University and University Hospital L. Pasteur', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Blanca Fuentes, MD, PhD', 'role': 'CONTACT', 'email': 'blanca.fuentes@salud.madrid.org'}], 'facility': 'La Paz University Hospital, Universidad Autónoma de Madrid, IdiPAZ Research Institute', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '47005', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Francisco Arenillas, MD, PhD', 'role': 'CONTACT', 'email': 'juanfrancisco.arenillas@uva.es'}], 'facility': 'Department of Medicine, University of Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '9007', 'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gian Marco De Marchis, MD, PhD', 'role': 'CONTACT', 'email': 'gian.demarchis@h-och.ch'}], 'facility': 'University Teaching Hospital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'BS10 5N', 'city': 'Bristol', 'state': 'UK', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sandeep Buddha, MD, MRCP', 'role': 'CONTACT', 'email': 'sandeep.buddha@nbt.nhs.uk'}], 'facility': 'Southmead Hospital, North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'SW17 0QT', 'city': 'London', 'state': 'UK', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Liquin Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'liqun.zhang@stgeorges.nhs.uk'}], 'facility': "St George's University Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0NN', 'city': 'London', 'state': 'UK', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Roland Veltkamp, MD, PhD', 'role': 'CONTACT', 'email': 'r.veltkamp@imperial.ac.uk'}], 'facility': 'Department of Brain Sciences, Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W6 8RF', 'city': 'London', 'state': 'UK', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': "Lucio D'Anna, MD, PhD", 'role': 'CONTACT', 'email': 'l.danna@imperial.ac.uk'}], 'facility': 'Department of Stroke and Neuroscience, Charing Cross Hospital, Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Simona Sacco, MD', 'role': 'CONTACT', 'email': 'simona.sacco@univaq.it', 'phone': '+39 0862433561'}, {'name': 'Matteo Foschi, MD', 'role': 'CONTACT', 'email': 'matteo.foschi@graduate.univaq.it', 'phone': '+39 3478929126'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From the end of the ASPERA-P study (10/02/2029) up to 10 years (10/02/2039)', 'ipdSharing': 'YES', 'description': 'We plan to share individual clinical data collected in the study with other researchers upon reasonable request, in line with ethical guidelines and data protection regulations. Data will be de-identified to protect participant confidentiality.', 'accessCriteria': "Access will be granted for purposes of replicating findings, conducting meta-analyses, or pursuing related research questions, subject to approval by the study's data governance committee and appropriate institutional review boards. Researchers will be required to sign data-sharing agreements to ensure proper use and compliance with confidentiality standards."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Simona Sacco', 'investigatorAffiliation': "University of L'Aquila"}}}}