NCT01959191|CompletedDMC
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Sponsor study identifier
observational
859
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)July 2013
Actual (reported)October 7, 2013
Actual (reported)October 9, 2013
Actual (reported)Major adverse cardiovascular events (MACEs)
The primary endpoint of the study was the 1-year incidence of MACEs, which included the following: (1) cardiac death, defined as death in the presence of acute coronary syndrome, sudden cardiac arrest with documented cardiac arrhythmia, or refractory congestive heart failure; 2) nonfatal MI; and (3) target vessel revascularization in relation to platelet reactivity as measured by the VerifyNow system.
1 year after off-pump coronary bypass surgery
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"
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"
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordConsecutive patients with indications for surgical myocardial revascularization
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, 120-752, South Korea
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.
Whole blood
859 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2013
First Posted
October 9, 2013
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Additional Benefit of Cilostazol to Dual Antiplatelet Therapy After Biolimus-eluting Stent Implantation
Contact the study team to confirm eligibility.
Primary Completion
June 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
October 9, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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