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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery

• Registration Number: NCT01959191
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-09
• Last Update Posted: 2013-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 859

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low platelet reactivity group	Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery	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"
high platelet reactivity group	Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery	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"

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of