Coronary Artery Disease
Conditions
Keywords
Platelet activity, CABG, off-pump surgery
Brief summary
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
Interventions
DRUGDual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
Sponsors
Yonsei University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACEs) | 1 year after off-pump coronary bypass surgery | 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. |
Countries
South Korea
Outcome results
None listed