Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-19 @ 1:36 AM
Study NCT ID:
NCT03759067
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2018-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Moderate to severe GUSTO bleeding', 'timeFrame': 'within 1week after PCI', 'description': 'Moderate GUSTO bleeding is defined as bleeding that requires blood transfusion but does not result in hemodynamic compromise. severe GUSTO bleeding is defined as a intracranial hemorrhage or hemodynamic compromise requiring treatment.'}], 'primaryOutcomes': [{'measure': '8hour mean CK-MB', 'timeFrame': '8hour after PCI', 'description': 'mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI'}, {'measure': '24hour mean CK-MB', 'timeFrame': '24hour after PCI', 'description': 'mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI'}], 'secondaryOutcomes': [{'measure': '8hour mean troponin-I', 'timeFrame': '8hour after PCI', 'description': 'mean troponin-I is checked 8hour after PCI'}, {'measure': 'Prevalence of periprocedural myocardial infarction (PMI)', 'timeFrame': '8hour or 24hour after PCI', 'description': 'Patients were considered to have PMI when their CK-MB level was elevated to \\>3 times the upper limit of normal, which was defined as 4.94 ng/mL.'}, {'measure': 'All cause death', 'timeFrame': '9 months after PCI', 'description': 'All death is evaluated using chart reviews and telephone calls.'}, {'measure': 'Coronary revascularization', 'timeFrame': '9 months after PCI', 'description': 'Coronary revascularization is evaluated using chart reviews and telephone. calls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clopidogrel loading', 'maintenance dose', 'periprocedural MI'], 'conditions': ['Angina, Stable']}, 'referencesModule': {'references': [{'pmid': '21670242', 'type': 'BACKGROUND', 'citation': 'Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study included 511 patients who underwent PCI because of angina during 2010-2011 at three Korean hospitals. Clopidogrel-naïve patients received either a loading dose (LD; 600 mg at 2-24 h before the procedure) or routine maintenance therapy (75 mg/day for ≥5 days) plus either a 300-mg reload (RL) or only the maintenance dose (MD).', 'detailedDescription': "Elevation of myocardial infarction markers after coronary stenting reflects periprocedural myonecrosis or periprocedural myocardial infarction (PMI), which is associated with an increase in cardiac events and mortality. Thus, we aimed to evaluate various clopidogrel pre-treatment methods for preventing PMI among patients undergoing conventional CAG for stable angina pectoris. The Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina patients (MECCA) study was a prospective, partially randomized, multi-center clinical trial. Between October 2010 and July 2011, 511 patients underwent PCI for angina pectoris at the Korean University Anam Hospital, the Eulji Hospital, and the Hanil General Hospital. Clopidogrel-naïve patients were enrolled to receive a loading dose (the LD group; clopidogrel at 600 mg, usually 2-24 h before the procedure) or routine therapy using daily clopidogrel doses (75 mg/day for ≥5 days). Patients receiving daily doses were randomized to receive either an additional 300-mg reload (the RL group) or no additional loading (the maintenance dose \\[MD\\] group). The 600-mg or 75-mg treatment regimens were selected at the physician's discretion. The primary outcome was creatinine kinase myocardial band (CK-MB) levels at several time points. The CK-MB levels were measured at baseline, 8 h, and 24 h, while troponin-I levels were measured at 8 h after the PCI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below\n\n 1. Treadmil test positive\n 2. ST-T change in resting ECG or 24-hour ECG\n 3. Regional wall motion abnormality in Echocardiography or cardiac MRI\n 4. Myocardial ischemia at MIBI scan\n 5. moderate to severe stenosis at coronary CT angiography\n 6. chest pain or dyspnea\n\nExclusion Criteria:\n\n* AST or ALT \\> 3 times upper normal limits\n* Serum creatinine \\> 2.0 mg/dL\n* chronic malaborption status (disorder or operation)\n* planned surgery within 1 year\n* pregnancy or breast-feeding patients\n* life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT03759067', 'acronym': 'MECCA', 'briefTitle': 'Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris', 'orgStudyIdInfo': {'id': 'KUMC_MECCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LD group', 'description': 'clopidogrel 600 mg once loading, usually 2-24 h before the procedure', 'interventionNames': ['Drug: clopidogrel 600mg']}, {'type': 'EXPERIMENTAL', 'label': 'MD group', 'description': 'After randomization, the routine therapy using daily clopidogrel 75mg', 'interventionNames': ['Drug: clopidogrel 75mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RL group', 'description': 'After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.', 'interventionNames': ['Drug: clopidogrel 75mg', 'Drug: Clopidogrel 300 mg']}], 'interventions': [{'name': 'clopidogrel 75mg', 'type': 'DRUG', 'otherNames': ['MD'], 'description': 'clopidogrel once daily 75mg', 'armGroupLabels': ['MD group', 'RL group']}, {'name': 'Clopidogrel 300 mg', 'type': 'DRUG', 'otherNames': ['RL'], 'description': 'clopidogrel 300mg reloading', 'armGroupLabels': ['RL group']}, {'name': 'clopidogrel 600mg', 'type': 'DRUG', 'otherNames': ['LD'], 'description': 'clopidogrel 600mg loading', 'armGroupLabels': ['LD group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Do-sun Lim', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}