Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 6:01 PM
Study NCT ID:
NCT00445835
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2007-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2007-03-08', 'studyFirstSubmitQcDate': '2007-03-08', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.', 'timeFrame': 'during the study', 'description': 'death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.'}], 'secondaryOutcomes': [{'measure': 'Incidence of each composite of the primary endpoint.', 'timeFrame': 'during the study', 'description': 'Incidence of each composite of the primary endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'myocardial infarction', 'atherothrombosis', 'atherosclerosis'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '29407124', 'type': 'DERIVED', 'citation': 'Collet JP, Cayla G, Ennezat PV, Leclercq F, Cuisset T, Elhadad S, Henry P, Belle L, Cohen A, Silvain J, Barthelemy O, Beygui F, Diallo A, Vicaut E, Montalescot G; AMERICA Investigators. Systematic detection of polyvascular disease combined with aggressive secondary prevention in patients presenting with severe coronary artery disease: The randomized AMERICA Study. Int J Cardiol. 2018 Mar 1;254:36-42. doi: 10.1016/j.ijcard.2017.11.081. Epub 2018 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery disease is the first cause of death related to atherothrombosis.', 'detailedDescription': 'Coronary artery disease is the first cause of death related to atherothrombosis. There is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. In addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. However, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. Conversely, the annual absolute risk of these lesions remains unknown. Consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. The Primary Objective and Primary Endpoint of the AMERICA study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high Risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Three vessel disease recently identified recently (\\<6 month)\n2. Accrue coronary syndromes in patients\\>75 years old (\\<1 month)\n\nExclusion criteria:\n\n1. Absence of significant coronary lesions\n2. Other causes of rise in the troponin level\n3. Patient\\<18 years old\n4. Pregnant women\n5. Patient without affiliation to National Social Security'}, 'identificationModule': {'nctId': 'NCT00445835', 'acronym': 'AMERICA', 'briefTitle': 'Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Active Detection and Management of the Extension of Atherothrombosis in High Risk Coronary Patients In Comparison With Standard of Care for Coronary Atherosclerosis: The AMERICA Study', 'orgStudyIdInfo': {'id': 'P060902'}, 'secondaryIdInfos': [{'id': 'PHAO 2006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BA :Active arm', 'description': 'A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis', 'interventionNames': ['Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds']}, {'type': 'OTHER', 'label': 'BC: Conservative arm', 'description': 'Conservative medical approach', 'interventionNames': ['Other: Conservative arm']}], 'interventions': [{'name': 'Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds', 'type': 'OTHER', 'description': 'A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis', 'armGroupLabels': ['BA :Active arm']}, {'name': 'Conservative arm', 'type': 'OTHER', 'description': 'Conservative medical approach', 'armGroupLabels': ['BC: Conservative arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Philippe COLLET, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Institut de l'Atherothrombose", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}