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

NCT02184884 | Completed

• 1 other identifier: 4-2014-0172
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome (ACS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of the major adverse cardiac events

  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.

  at 30 days after surgery

Study Arms (2)

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

Interventions

MACE after OPCAB DEVICE

MACE group

without MACE after OPCAB DEVICE

no MACE group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass surgery

You may qualify if:

• the patients with ACS undergoing OPCAB
• the patients over 20 years of age
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Soh S, Shin YR, Song JW, Choi JH, Kwak YL, Shim JK. Platelet Reactivity and Outcomes after Off-Pump Coronary Surgery in Acute Coronary Syndrome Patients. J Clin Med. 2022 Jun 8;11(12):3285. doi: 10.3390/jcm11123285.

  PMID: 35743360 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular 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: June 30, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

KR (1)