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Completed

NCT Number: NCT03759067

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

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).

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Key information

Conditions

Angina, Stable Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clopidogrel 75mg

Drug

clopidogrel once daily 75mg

Other names: MD

Clopidogrel 300 mg

Drug

clopidogrel 300mg reloading

Other names: RL

clopidogrel 600mg

Drug

clopidogrel 600mg loading

Other names: LD

Primary outcomes

  1. 8hour mean CK-MB

    Time frame: 8hour after PCI

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

  2. 24hour mean CK-MB

    Time frame: 24hour after PCI

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

Secondary outcomes

  1. 8hour mean troponin-I

    Time frame: 8hour after PCI

    mean troponin-I is checked 8hour after PCI

  2. Prevalence of periprocedural myocardial infarction (PMI)

    Time frame: 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.

  3. All cause death

    Time frame: 9 months after PCI

    All death is evaluated using chart reviews and telephone calls.

  4. Coronary revascularization

    Time frame: 9 months after PCI

    Coronary revascularization is evaluated using chart reviews and telephone. calls.

Other outcomes

  1. Moderate to severe GUSTO bleeding

    Time frame: within 1week after PCI

    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.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Acronym: MECCA

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 29, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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