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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02184884

Enrollment

195

Registered

2014-07-09

Start date

2014-07-31

Completion date

2020-03-30

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome (ACS)

Keywords

off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome

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.

Interventions

DEVICEMACE after OPCAB

DEVICEwithout MACE after OPCAB

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026