Clinical trial NCT03759067: Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients
Official title: Prospective Partially Randomized Comparison of Clopidogrel Loading Versus Maintenance Dosing to Prevent Periprocedural Myocardial Infarction After Stenting for a Stable Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina, Stable
Keywords: clopidogrel loading
maintenance dose
periprocedural MI
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 511
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 8hour mean CK-MB
timeFrame: 8hour after PCI
measure: 24hour mean CK-MB
timeFrame: 24hour after PCI
Secondary outcomes:
measure: 8hour mean troponin-I
timeFrame: 8hour after PCI
measure: Prevalence of periprocedural myocardial infarction (PMI)
timeFrame: 8hour or 24hour after PCI
measure: All cause death
timeFrame: 9 months after PCI
measure: Coronary revascularization
timeFrame: 9 months after PCI
Other outcomes:
measure: Moderate to severe GUSTO bleeding
timeFrame: within 1week after PCI
Locations:
Study officials:
References:
citation: 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.