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

Angina, Stable Clinical Trial

— MECCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759067
• Other study ID #: KUMC_MECCA
• Status: Completed
• Phase: N/A
• Start date: October 18, 2010
• Est. completion date: July 31, 2013

Study information

• Verified date: November 2018
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: July 31, 2013
• Est. primary completion date: January 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable

Intervention

Drug:
• clopidogrel 75mg
clopidogrel once daily 75mg
• Clopidogrel 300 mg
clopidogrel 300mg reloading
• clopidogrel 600mg
clopidogrel 600mg loading

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	8hour mean CK-MB	mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI	8hour after PCI
Primary	24hour mean CK-MB	mean CK-MB(creatinine kinase myocardial band) is checked 8hour after PCI	24hour after PCI
Secondary	8hour mean troponin-I	mean troponin-I is checked 8hour after PCI	8hour after PCI
Secondary	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
Secondary	All cause death	All death is evaluated using chart reviews and telephone calls.	9 months after PCI
Secondary	Coronary revascularization	Coronary revascularization is evaluated using chart reviews and telephone. calls.	9 months after PCI

External Links

•   GUSTO bleeding