Acute Coronary Syndrome (ACS) Clinical Trial
NCT number | NCT02184884 |
Other study ID # | 4-2014-0172 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | March 30, 2020 |
Verified date | May 2020 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 195 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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