Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT01952392
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2013-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4992}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-09-27', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical information', 'timeFrame': 'At baseline visit', 'description': 'History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors'}, {'measure': 'Drug exposure', 'timeFrame': 'Current', 'description': 'Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.'}, {'measure': 'Drug exposure', 'timeFrame': 'Recent', 'description': 'Recent exposure: in the week (7 days) preceding the recurrent MI. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.'}, {'measure': 'Drug exposure', 'timeFrame': 'Past', 'description': 'Past exposure: more than a week (7 days) before the recurrent MI and until the ACS index. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.'}], 'secondaryOutcomes': [{'measure': 'Other medical events of interest', 'timeFrame': 'During follow-up (up to 12 months)', 'description': 'rMI, stroke, bleeding, death'}]}, 'conditionsModule': {'keywords': ['Effectiveness study', 'Acute coronary Syndrome', 'Real-life', 'France'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1819&filename=CSR_Synopsis_AReMIS.pdf', 'label': 'CSR\\_Synopsis'}]}, 'descriptionModule': {'briefSummary': 'Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome', 'detailedDescription': "AReMIS (Antiplatelet and Recurrent Myocardial Infarction Study) To compare the relative risk of new myocardial infarction (recurrent myocardial infarction or 'rMI') in patients with a history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or more, both genders,with an acute coronary syndrome, agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18 years or more, both genders, with an acute coronary syndrome (ACS), agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.\n\nNo Exclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT01952392', 'acronym': 'AReMIS', 'briefTitle': 'Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'NIS-CFR-BRI-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Patients aged 18 years or more with an acute coronary syndrome, agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary'}, {'label': 'Case group', 'description': 'Patients aged 18 years or more with a history of acute coronary syndrome (i.e. a recurrent MI after myocardial history or unstable angina), agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}