Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-09 @ 9:21 PM
Study NCT ID:
NCT03658005
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-04-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of unbound ticagrelor and its metabolite', 'timeFrame': 'at 3 hours after administration of the first dose of ticagrelor', 'description': 'Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin'}, {'measure': 'concentration of unbound ticagrelor and its metabolite', 'timeFrame': 'at 6 hours after administration of the first dose of ticagrelor', 'description': 'Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin'}, {'measure': 'concentration of unbound ticagrelor and its metabolite', 'timeFrame': 'at 12 hours after administration of the first dose of ticagrelor', 'description': 'Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin'}], 'secondaryOutcomes': [{'measure': 'Assess the method of determination of ticagrelor concentration', 'timeFrame': 'at 3 hours after administration of the first dose of ticagrelor', 'description': 'Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS'}, {'measure': 'Assess the method of determination of ticagrelor concentration', 'timeFrame': 'at 6 hours after administration of the first dose of ticagrelor', 'description': 'Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS'}, {'measure': 'Assess the method of determination of ticagrelor concentration', 'timeFrame': 'at 12 hours after administration of the first dose of ticagrelor', 'description': 'Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ticagrelor', 'acute coronary syndrome', 'anti-platelet drug'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess:\n\n* the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor\n* ticagrelor and its metabolite levels by LC-MS/MS', 'detailedDescription': 'Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.\n\nIn this context, the aim of the study is to assess:\n\n* the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor\n* ticagrelor and its metabolite levels by LC-MS/MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the Cardiology department with a main diagnosis of acute coronary syndrome and treated with a treatment combination including ticagrelor and aspirin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 18 years and less than 90 years,\n* Patients admitted for myocardial infarction treated with ticagrelor in association with aspirin.\n* Patients affiliated to a social security system (or be a beneficiary thereof);\n* Sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements.\n\nExclusion Criteria:\n\n* Patients with limited legal capacity or patients under legal guardianship\n* Patients under judicial protection\n* Patients not affiliated to any social security system\n* Patients taking any antiplatelet agent other than ticagrelor Patients taking ticagrelor for \\<48 hours (treatment not stabilised) Patients with hemoglobin concentration \\<10 g/dL on the most recent blood test'}, 'identificationModule': {'nctId': 'NCT03658005', 'acronym': 'PLATIME', 'briefTitle': 'Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients', 'orgStudyIdInfo': {'id': 'P/2018/371'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'Adult (\\>18 years, \\<90 years) patients admitted and treated for acute myocardial infarction, and whose treatment includes ticagrelor in association with aspirin.\n\nBlood samples will be taken at 3 timepoints between two doses of ticagrelor (taken at 12 hours interval).', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': '3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and \\>6h, between two doses of ticagrelor (taken at 0 and 12 hours).', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ELISE ROBERT', 'role': 'CONTACT', 'email': 'e1robert@chu-besancon.fr', 'phone': '0381219086'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Jennifer Lagoutte-Renosi, MPharm', 'role': 'CONTACT', 'email': 'jlagoutte@chu-besancon.fr', 'phone': '+33370632379'}], 'overallOfficials': [{'name': 'Nicolas Meneveau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Cardiology, CHU Besancon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}