Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass

N/ACompletedNCT01959191

Yonsei University859 enrolled

Overview

Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design * Prospective, observational, single-center study * Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled. * Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system. * Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint. * Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups). * The primary and secondary endpoints will be compared between two groups

Study Type

OBSERVATIONAL

Enrollment

859

Conditions

Coronary Artery Disease

Interventions

Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with indications for surgical myocardial revascularization * Patients who undergo off-pump coronary artery bypass * Age between 19\~80 years * Patients with signed informed consent Exclusion Criteria: * Patients with combined surgery with coronary bypass grafting * On-pump conversion * Patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis * Patients with chronic treatment with proton pump inhibitors * Patients with preoperative bleeding * Thrombocytopenia (Platelet count 70,000/ml) * Re-do surgery * Early death before the measurement of platelet reactivity

Outcomes

Primary Outcomes

Major adverse cardiovascular events (MACEs)

The primary endpoint of the study was the 1-year incidence of MACEs, which included the following: (1) cardiac death, defined as death in the presence of acute coronary syndrome, sudden cardiac arrest with documented cardiac arrhythmia, or refractory congestive heart failure; 2) nonfatal MI; and (3) target vessel revascularization in relation to platelet reactivity as measured by the VerifyNow system.

Time frame: 1 year after off-pump coronary bypass surgery