Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 5:29 PM
Study NCT ID:
NCT01431495
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2011-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-08', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- study the respective effects of Pidogrel ® and Plavix ® on platelet aggregation through the test VerifyNow ® - Time to first occurrence of post-randomization major adverse cardiac events (MACE)', 'timeFrame': '06 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['platelet agregation', 'clopidogrel', 'major adverse cardiac events (MACE)'], 'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to demonstrate non-inferiority of Pidogrel ® compared to Plavix ® in patients with coronary disease:\n\n* Primary Outcome Measures: measure of platelet reactivity by VerifyNow assay after 600 mg loading dose or after the last maintenance dose (75 mg).\n* Secondary Outcome Measures: Time to first occurrence of major cardio-vascular events (MACE).\n* Safety Criteria: severe bleeding (GUSTO scale).', 'detailedDescription': 'after randomization of patients in both groups (Plavix or Pidogrel), the measure of platelet activity by the VerifyNow assay, 4 to 12 hours after the loading dose of 600mg or after the last dose of clopidogrel for patients on maintenance dose. The VerifyNow assay will determine: - The PRU:-P2Y12 Reaction Units-\n\n-% Of platelet inhibition It will be considered low responder or clopidogrel resistant patient with PRU\\> 235 or %inhibition \\<15%.\n\nMonitoring of patients included in the study will take place over a period of 12 months, MACE will be notified and dated. MACE criteria are: angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft, and stroke.\n\nEach hemorrhagic event will be notified and classified according to the GUSTO scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female,\n* Old (e) over 20 years\n* Patients hospitalized for acute coronary syndrome (Whatever the T and troponin)\n* Patients with proven coronary candidates for treatment with clopidogrel (who received a loading dose of 600mg over 2 hours and treated with 75mg / d of clopidogrel for longer than 7 days)\n\nExclusion Criteria:\n\n* Patients unwilling.\n* Patient participating in another study.\n* Patients with cardiogenic shock\n* Patient on anti GpIIbIIIa or stopped less than 72 hours before the test aggregability\n* Patients scheduled for surgery in less than 6 months.\n* Patients candidates for coronary angioplasty\n* Patients who underwent TAC + / - bare stent fewer than 30 days.\n* Patients who underwent stenting with ATC active there is less than 12 months.\n* ischemic stroke older than 6 weeks.\n* History of hemorrhagic stroke (any time)\n* Patients on warfarin or candidates\n* Patients with a different anti ADP (ticlopidine, prasugrel)\n* Patients with indication for clopidogrel-cons (side effects, bleeding ...)\n* Thrombocytopenia \\<100000/mm3\n* anemia (Ht \\<30%)\n* Thrombocythaemia (Ht\\> 52%)\n* Patients seeking treatment for an elective forms of Clopidogrel.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01431495', 'acronym': '(CAPP)', 'briefTitle': 'Clinical Assessment of Pidogrel® Versus Plavix® (CAPP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Les Laboratoires des Médicaments Stériles'}, 'officialTitle': 'Clinical Assessment of Pidogrel® Versus Plavix®', 'orgStudyIdInfo': {'id': 'CAPP-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'plavix', 'description': 'patient treated by the princeps', 'interventionNames': ['Drug: Plavix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pidogrel', 'description': 'patient treated by Pidogrel', 'interventionNames': ['Drug: Pidogrel']}], 'interventions': [{'name': 'Pidogrel', 'type': 'DRUG', 'description': 'Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.', 'armGroupLabels': ['Pidogrel']}, {'name': 'Plavix', 'type': 'DRUG', 'description': 'Plavix(R) 75 mg/day for period ranging from 1 to 6 months.', 'armGroupLabels': ['plavix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1007', 'city': 'Tunis', 'state': 'Tunis BAB Souika', 'country': 'Tunisia', 'facility': 'cardiology department, hospital La RABTA', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Rachid MECHMECHE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'hospital La RABTA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Les Laboratoires des Médicaments Stériles', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}