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

NCT ID: NCT03759067

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-18
• Study Completion Date: 2013-07-31

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.

Conditions

Angina, Stable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LD group

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

Group Type: ACTIVE_COMPARATOR

clopidogrel 600mg

Intervention Type: DRUG

clopidogrel 600mg loading

MD group

After randomization, the routine therapy using daily clopidogrel 75mg

Group Type: EXPERIMENTAL

clopidogrel 75mg

Intervention Type: DRUG

clopidogrel once daily 75mg

RL group

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

Group Type: ACTIVE_COMPARATOR

clopidogrel 75mg

Intervention Type: DRUG

clopidogrel once daily 75mg

Clopidogrel 300 mg

Intervention Type: DRUG

clopidogrel 300mg reloading

Interventions

clopidogrel 75mg

clopidogrel once daily 75mg

Intervention Type: DRUG

Clopidogrel 300 mg

clopidogrel 300mg reloading

Intervention Type: DRUG

clopidogrel 600mg

clopidogrel 600mg loading

Intervention Type: DRUG

Other Intervention Names

MD; RL; LD

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Do-sun Lim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 21670242 (View on PubMed)

Other Identifiers

KUMC_MECCA

Identifier Type: -

Identifier Source: org_study_id