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

NCT01959191 | Completed DMC

• 1 other identifier: 4-2011-0309
• Study Type: observational
• Target: 859
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Platelet activity, CABG, off-pump surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low platelet reactivity group

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"

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

high platelet reactivity group

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"

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

Interventions

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

Low platelet reactivity group; high platelet reactivity group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with indications for surgical myocardial revascularization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related 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.

  PMID: 18804738 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Whole blood

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: January 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 9, 2013

Record last verified: 2013-10

Locations

KR (1)