Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris

Conditions
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Angina, Stable

Intervention / Treatment
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* Drug: clopidogrel 75mg
* Drug: Clopidogrel 300 mg
* Drug: clopidogrel 600mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below Treadmil test positive ST-T change in resting ECG or 24-hour ECG Regional wall motion abnormality in Echocardiography or cardiac MRI Myocardial ischemia at MIBI scan moderate to severe stenosis at coronary CT angiography chest pain or dyspnea Exclusion Criteria: AST or ALT > 3 times upper normal limits Serum creatinine > 2.0 mg/dL chronic malaborption status (disorder or operation) planned surgery within 1 year pregnancy or breast-feeding patients life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LD group<br>clopidogrel 600 mg once loading, usually 2-24 h before the procedure | Drug: clopidogrel 600mg<br>* clopidogrel 600mg loading<br>* Other names: LD;|
| Experimental: MD group<br>After randomization, the routine therapy using daily clopidogrel 75mg | Drug: clopidogrel 75mg<br>* clopidogrel once daily 75mg<br>* Other names: MD;|
| Active Comparator: RL group<br>After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose. | Drug: clopidogrel 75mg<br>* clopidogrel once daily 75mg<br>* Other names: MD;Drug: Clopidogrel 300 mg<br>* clopidogrel 300mg reloading<br>* Other names: RL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8hour mean CK-MB | mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI | 8hour after PCI | 
| 24hour mean CK-MB | mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI | 24hour after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8hour mean troponin-I | mean troponin-I is checked 8hour after PCI | 8hour after PCI | 
| Prevalence of periprocedural myocardial infarction (PMI) | 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. | 8hour or 24hour after PCI | 
| All cause death | All death is evaluated using chart reviews and telephone calls. | 9 months after PCI | 
| Coronary revascularization | Coronary revascularization is evaluated using chart reviews and telephone. calls. | 9 months after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel loading, maintenance dose, periprocedural MI