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Trial record 30 of 507 for:    ASPIRIN AND P2

Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass

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ClinicalTrials.gov Identifier: NCT01959191
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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

  • 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

Condition or disease Intervention/treatment
Coronary Artery Disease Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery

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Study Type : Observational
Actual Enrollment : 859 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : January 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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"
Drug: 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"
Drug: 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




Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACEs) [ Time Frame: 1 year after off-pump coronary bypass surgery ]
    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.


Biospecimen Retention:   None Retained
Whole blood


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with indications for surgical myocardial revascularization
Criteria

Inclusion Criteria:

  • Patients with indications for surgical myocardial revascularization
  • Patients who undergo off-pump coronary artery bypass
  • Age between 19~80 years
  • Patients with signed informed consent

Exclusion Criteria:

  • Patients with combined surgery with coronary bypass grafting
  • 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

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): NCT01959191


Locations
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Korea, Republic of
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01959191     History of Changes
Other Study ID Numbers: 4-2011-0309
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Yonsei University:
Platelet activity, CABG, off-pump surgery
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents