Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery

Completed

• Conditions: Acute Coronary Syndrome (ACS)
• Interventions: Device: without MACE after OPCAB; Device: MACE after OPCAB

• Registration Number: NCT02184884
• Lead Sponsor: Yonsei University

Brief Summary

The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.

The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-30
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-09
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

1. the patients with ACS undergoing OPCAB
2. the patients over 20 years of age
3. the patient who have been taking [100 mg of Aspirin] and [75 mg of clopidogrel or 180 mg of ticagrelor] for more than one week and who continue within 3 to 5 days prior to surgery

Read More

Exclusion Criteria

1. re-operation or emergency operation
2. the patients with bleeding tendency of decreased liver function
3. Left ventricular ejection fraction < 40% by echo
4. preoperative hematocrit < 33% or platelet count < 100,000/mm3 or creatinine > 1.4 mg/dL
5. abnormal preoperative prothrombin time or activated partial thromboplastin time
6. preoperative use of other PO antiplatelet drugs or PO anticoagulants

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no MACE group	without MACE after OPCAB	the patients without MACE after OPCAB
MACE group	MACE after OPCAB	the patients with MACE after OPCAB

Primary Outcome Measures

Name	Time	Method
Rate of the major adverse cardiac events	at 30 days after surgery	major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine; 🇰🇷 Seoul, Korea, Republic of