Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-26 @ 8:49 AM
Study NCT ID:
NCT06535568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of major adverse cardiovascular events (MACE) at 12 months', 'timeFrame': '12 months', 'description': 'Non-inferiority of SAPT vs. DAPT in terms of MACE, a composite of all-cause mortality, target vessel revascularization-TVR, target vessel spontaneous MI at 12 months, after successful DCB angioplasty.'}, {'measure': 'Rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5)', 'timeFrame': '12 months', 'description': 'Superiority of SAPT vs. DAPT in terms of clinically relevant bleeding events (BARC 2, 3, or 5) at 12 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DCB', 'Angioplasty', 'Paclitaxel', 'Antiplatelet treatment', 'Single antiplatelet therapy (SAPT)', 'Dual antiplatelet therapy (DAPT)', 'High bleeding risk (HBR)', 'MACE', 'Native CAD', 'stable or unstable coronary syndromes'], 'conditions': ['Coronary Disease', 'Heart Diseases', 'Cardiovascular Diseases', 'Myocardial Ischemia', 'Atherosclerosis', 'Arterial Occlusive Diseases', 'Vascular Diseases', 'Coronary Artery Disease', 'Acute Coronary Syndrome', 'Coronary Stenosis', 'Molecular Mechanisms of Pharmacological Action', 'Enzyme Inhibitors', 'MTOR Inhibitors', 'Protein Kinase Inhibitors', 'Physiological Effects of Drugs', 'Immunosuppressive Agents', 'Antineoplastic Agents', 'High Bleeding Risk', 'Single Antiplatelet Therapy', 'Dual Antiplatelet Therapy', 'Cyclooxygenase Inhibitors', 'P2Y12 Inhibitor', 'Platelet Aggregation Inhibitors', 'Aspirin', 'Clopidogrel']}, 'descriptionModule': {'briefSummary': 'International multicenter, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the rate of ischemic and bleeding adverse events of a single antiplatelet regimen (SAPT) since the time of PCI with latest generation DCB in elderly or HBR population with stable or unstable coronary syndromes.', 'detailedDescription': 'The purpose of PICCOLETO IV study is to observe and evaluate the efficacy and safety of a single antiplatelet therapy (SAPT) after successful DCB angioplasty with Essential Pro (Drug-coated balloon (iVascular) in native coronary artery disease in vessels with diameter \\>=2.0 and \\<=4.0 mm as compared to the routine dual antiplatelet therapy (DAPT). Patients with stable or unstable coronary syndromes will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* successful PCI with solo-DCB just performed, in 1, 2 or 3 coronary vessels;\n* stable or unstable coronary syndromes;\n* de novo coronary lesions in vessels with diameter \\>=2.0 and \\<=4.0 mm (visual estimation);\n* informed consent to participate in the study;\n* at least one of the following criteria: \\>=75 y.o.; high bleeding risk (ARC criteria)\n\nExclusion Criteria:\n\n* stent implantation during index or recent (\\<6 months) procedure;\n* patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, contrast media, which cannot be adequately pre-medicated;\n* patients participating in another clinical study; - pregnancy at the time of hospitalization;\n* ST-elevation myocardial infarction;\n* life expectancy \\<12 months;\n* left ventricular ejection fraction \\<30%;\n* visible thrombus at lesion site;\n* target lesion/vessel with any of the following characteristics:\n\n * severe and/or \\>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);\n * left main stem stenosis \\>50%;\n * target lesion is in the left main stem;\n * chronic total occlusion with anticipated necessity of retrograde approach;\n * lesion is in a bypass graft.'}, 'identificationModule': {'nctId': 'NCT06535568', 'acronym': 'PICCOLETO IV', 'briefTitle': 'Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Ricerca e Innovazione Cardiovascolare ETS'}, 'officialTitle': 'International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons', 'orgStudyIdInfo': {'id': 'PICCOLETO IV-EPIC 38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single antiplatelet therapy', 'interventionNames': ['Device: Drug-coated balloon', 'Drug: Single antiplatelet therapy (SAPT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual antiplatelet therapy', 'interventionNames': ['Device: Drug-coated balloon', 'Drug: Dual antiplatelet therapy (DAPT)']}], 'interventions': [{'name': 'Drug-coated balloon', 'type': 'DEVICE', 'description': 'Essential pro (iVascular, Barceona, Spain) paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.', 'armGroupLabels': ['Dual antiplatelet therapy', 'Single antiplatelet therapy']}, {'name': 'Single antiplatelet therapy (SAPT)', 'type': 'DRUG', 'description': 'The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.', 'armGroupLabels': ['Single antiplatelet therapy']}, {'name': 'Dual antiplatelet therapy (DAPT)', 'type': 'DRUG', 'description': "The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.", 'armGroupLabels': ['Dual antiplatelet therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bernardo Cortese', 'role': 'CONTACT', 'email': 'bcortese@gmail.com', 'phone': '+393481123968'}, {'name': 'Sara Malakouti', 'role': 'CONTACT', 'email': 'sara.malakouti@fondazioneric.or'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Ricerca e Innovazione Cardiovascolare ETS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación EPIC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}