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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome (ACS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MACE group

the patients with MACE after OPCAB

MACE after OPCAB

Intervention Type DEVICE

no MACE group

the patients without MACE after OPCAB

without MACE after OPCAB

Intervention Type DEVICE

Interventions

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MACE after OPCAB

Intervention Type DEVICE

without MACE after OPCAB

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No