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

Not Applicable

Completed

• Conditions: Angina, Stable
• Interventions: Drug: clopidogrel 75mg; Drug: clopidogrel 600mg; Drug: Clopidogrel 300 mg

• Registration Number: NCT03759067
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10-18
• Primary Completion: 2012-01-31
• Study Completion: 2013-07-31
• Status Verified: 2018-11
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-29
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

• Written informed consent and, stable angina pectoris and, at least 1 ischemic evidence below

  1. Treadmil test positive
  2. ST-T change in resting ECG or 24-hour ECG
  3. Regional wall motion abnormality in Echocardiography or cardiac MRI
  4. Myocardial ischemia at MIBI scan
  5. moderate to severe stenosis at coronary CT angiography
  6. chest pain or dyspnea

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RL group	clopidogrel 75mg	After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.
LD group	clopidogrel 600mg	clopidogrel 600 mg once loading, usually 2-24 h before the procedure
RL group	Clopidogrel 300 mg	After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.
MD group	clopidogrel 75mg	After randomization, the routine therapy using daily clopidogrel 75mg

Primary Outcome Measures

Name	Time	Method
24hour mean CK-MB	24hour after PCI	mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI
8hour mean CK-MB	8hour after PCI	mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI

Secondary Outcome Measures

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