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

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ClinicalTrials.gov Identifier: NCT02184884
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome (ACS) Device: MACE after OPCAB Device: without MACE after OPCAB

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Study Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : July 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. Rate of the major adverse cardiac events [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass surgery
Criteria

Inclusion Criteria:

  1. the patients with ACS undergoing OPCAB
  2. the patient administrate aspirin 100 mg and clopidogrel 75 mg at least 7 days and continue within 3days before 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184884


Contacts
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Contact: Jae-Kwang Shim, MD 82-10-5065-2733 aneshim@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae-Kwang Shim, MD    82-10-5065-2733    aneshim@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02184884     History of Changes
Other Study ID Numbers: 4-2014-0172
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Keywords provided by Yonsei University:
off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome

Additional relevant MeSH terms:
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Myocardial Ischemia
Clopidogrel
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs