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

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

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).

Study Overview

• Status: Completed
• Conditions: Angina, Stable
• Intervention / Treatment: Drug: clopidogrel 600mg; Drug: clopidogrel 75mg; Drug: Clopidogrel 300 mg

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 Type: Interventional
• Enrollment (Actual): 511
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to severe GUSTO bleeding	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.	within 1week after PCI

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2010
• Primary Completion (ACTUAL): January 31, 2012
• Study Completion (ACTUAL): July 31, 2013

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: maintenance dose; clopidogrel loading; periprocedural MI
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: KUMC_MECCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No