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

Yonsei University

Status: Completed

Conditions: Coronary Artery Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT01959191

4-2011-0309

Details and patient eligibility

About

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

Enrollment: 859 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

859 participants in 2 patient groups

Low platelet reactivity group

Description:

Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group"

Treatment:

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

high platelet reactivity group

Description:

Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group"

Treatment:

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