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

Korea University

Status: Completed

Conditions: Angina, Stable

Treatments: Drug: clopidogrel 75mg; Drug: Clopidogrel 300 mg; Drug: clopidogrel 600mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03759067

KUMC_MECCA

Details and patient eligibility

About

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).

Full 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.

Enrollment: 511 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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511 participants in 3 patient groups

LD group

Active Comparator group

Description:

clopidogrel 600 mg once loading, usually 2-24 h before the procedure

Treatment:

Drug: clopidogrel 600mg

MD group

Experimental group

Description:

After randomization, the routine therapy using daily clopidogrel 75mg

Treatment:

Drug: clopidogrel 75mg

RL group

Active Comparator group

Description:

After randomization, additional clopidogrel 300 mg reloading for patients who were taking a maintenance dose.

Treatment:

Drug: Clopidogrel 300 mg

Drug: clopidogrel 75mg