Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass
NCT ID: NCT01959191
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
859 participants
OBSERVATIONAL
2008-01-31
2013-07-31
Brief Summary
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* Prospective, observational, single-center study
* Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled.
* Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system.
* Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint.
* Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups).
* The primary and secondary endpoints will be compared between two groups
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Low platelet reactivity group
Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group"
Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
high platelet reactivity group
Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group"
Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
Interventions
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Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
Eligibility Criteria
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Inclusion Criteria
* Patients who undergo off-pump coronary artery bypass
* Age between 19\~80 years
* Patients with signed informed consent
Exclusion Criteria
* On-pump conversion
* Patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis
* Patients with chronic treatment with proton pump inhibitors
* Patients with preoperative bleeding
* Thrombocytopenia (Platelet count 70,000/ml)
* Re-do surgery
* Early death before the measurement of platelet reactivity
19 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, , South Korea
Countries
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References
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Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038.
Other Identifiers
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4-2011-0309
Identifier Type: -
Identifier Source: org_study_id