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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year

Primary outcomes

Major adverse cardiovascular events (MACEs)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Oct 9, 2013
Registry last updated: Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed