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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02184884
• Collaborator: (none)
• Enrollment: 195
• Location: 1
• Actual Duration (Months): 69
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome (ACS)	Device: MACE after OPCAB; Device: without MACE after OPCAB

Study Design

• Study Type: Observational
• Actual Enrollment: 195 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
MACE group the patients with MACE after OPCAB	Device: MACE after OPCAB
no MACE group the patients without MACE after OPCAB	Device: without MACE after OPCAB

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02184884
• Other Study ID Numbers: 4-2014-0172
• First Posted: Jul 9, 2014
• Last Update Posted: May 29, 2020
• Last Verified: May 1, 2020

• Keywords provided by Yonsei University: off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of May 29, 2020