Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-28 @ 11:34 PM
Study NCT ID:
NCT01135667
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2010-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000068799', 'term': 'Prasugrel Hydrochloride'}], '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'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heparin ADP by Multiplate', 'timeFrame': '30 days', 'description': 'Test of platelet inhibition (ADP receptor mediated) after 30 days of intensifiet anti platelet therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clopidogrel', 'prasugrel', 'low responder', 'multiplate', 'verify now'], 'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Acute Coronary Syndromes']}, 'descriptionModule': {'briefSummary': 'All patients undergoing elective or sub-acute PCI are screened by MULTIPLATE test for clopidogrel low-responsiveness after receiving 600 mg clopidogrel the day before.\n\nA cut off value has previously been established. Only low-responders with Multiplate values above the cut off value are included in the study. The patients are randomized to either clopidogrel 150 mg once daily or Prasugrel 10 mg (age \\> 75 og bodyweight \\< 60 kg 5 mg)once daily for 30 days after the procedure.\n\nFollow up will be at 30 days after PCI were another MULTIPLATE test will be performed.\n\nPrimary endpoint:Platelet inhibition (by MULTIPLATE) after 30 days of intensified antiplatelet therapy.\n\nClinical endpoints such as bleeding complications (GUSTO, TIMI) during treatment, and major adverse cardiac events (MACE) at 30 days will be collected and reported but the study size does not allow for formal statistical analysis The study ends by the 30 days follow up visit and all patients continue with clopidogrel 75 mg once daily for another 11 months (not study related)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCI with stenting and Multiplate hep-ADP \\> 70 U despite clopidogrel loading\n\nExclusion Criteria:\n\n* need for vit K antagonist\n* women with childbearing potential\n* breastfeeding women\n* Planned surgery within 6 months\n* Intolerance to clopidogrel, prasugrel or aspirin\n* previous stroke'}, 'identificationModule': {'nctId': 'NCT01135667', 'acronym': 'TAILOR', 'briefTitle': 'Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Thrombocytes And IndividuaLization of ORal Antiplatelet Treatment After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'TAILOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'clopidogrel', 'description': 'clopidogrel 150 mg once daily for 30 days (and then 75 mg for additional 11 months - not study related)', 'interventionNames': ['Drug: clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prasugrel', 'description': 'Prasugrel 10 mg once daily for 30 days (and then clopidogrel 75 mg once daily for additional 11 months - not study related)', 'interventionNames': ['Drug: Prasugrel 10 mg']}], 'interventions': [{'name': 'clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'clopidogrel 150 mg once daily for 30 days', 'armGroupLabels': ['clopidogrel']}, {'name': 'Prasugrel 10 mg', 'type': 'DRUG', 'otherNames': ['Efient'], 'description': 'Prasugrel 10 mg once daily for 30 days', 'armGroupLabels': ['Prasugrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen O', 'country': 'Denmark', 'facility': 'Rigshospitalet, Department of Cardiology, 2013'}], 'overallOfficials': [{'name': 'Lene Holmvang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lene Holmvang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD DMSc', 'investigatorFullName': 'Lene Holmvang', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}