Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00432120
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2007-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-28', 'studyFirstSubmitDate': '2007-02-05', 'studyFirstSubmitQcDate': '2007-02-05', 'lastUpdatePostDateStruct': {'date': '2008-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary end point was the first clinical occurrence of any of the following: death / periprocedural myocardial infarction / stroke or transient ischemic attack / re-intervention', 'timeFrame': 'within 7 days'}], 'secondaryOutcomes': [{'measure': 'Secondary end-points were periprocedural troponin elevation (> 3x ULN), TIMI-flow after PCI, bleeding complications and each individual component of the combined primary endpoint', 'timeFrame': 'within 7 day'}]}, 'conditionsModule': {'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'Clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. However, the vast majority of patients in the current interventional cardiology practice do not undergo planned PCI, but rather "ad-hoc" PCI performed immediately after coronary angiography . Whether clopidogrel should be administered as pre-treatment to all patients undergoing elective CAG with the aim to ensure therapeutic levels at the time of possible ad-hoc PCI is not known.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Elective CAG for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome)\n3. Signed written informed consent\n\nExclusion Criteria:\n\n1. Thienopyridine treatment in previous two weeks\n2. Contraindication for clopidogrel\n3. CAG scheduled less than 6 hours after potential randomization\n4. Clinically significant bleeding (i.e. with hemoglobin fall by \\> 50 g/l and/or requiring transfusions or surgery) in previous 3 months.'}, 'identificationModule': {'nctId': 'NCT00432120', 'briefTitle': 'Clopidogrel Only Before Percutaneous Coronary Intervention or Before Every Coronarography?', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Clopidogrel Loading Dose for ad-Hoc Percutaneous Coronary Intervention Immediately Following Elective Coronary Angiography: Randomized Multicenter Trial Comparing Pre-Treatment > 6 Hours Before Every Angiography vs. Cath-Lab Administration After Angiography (Just Before Intervention): the PRAGUE-8 Trial.', 'orgStudyIdInfo': {'id': 'PRAGUE 8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': '"nonselective" - clopidogrel 600 mg \\>6 hours before coronary angiography;', 'interventionNames': ['Drug: clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '"selective" - clopidogrel 600 mg in the cath-lab after coronary angiography, only in case of percutaneous coronary intervention', 'interventionNames': ['Drug: clopidogrel']}], 'interventions': [{'name': 'clopidogrel', 'type': 'DRUG', 'description': 'To compare two different clopidogrel regimens on the outcomes of patients undergoing elective coronary angiography ± ad-hoc percutaneous coronary intervention', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Petr Widimsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague, Czech Republic'}, {'name': 'Zuzana Motovska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Prague, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}}}}