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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959191
• Other study ID #: 4-2011-0309
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 7, 2013
• Start date: January 2008
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board (Severance Hospital)
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Dual 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

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year after off-pump coronary bypass surgery	No