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

NCT01959191 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 859

Last updated 2013-10-09

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01959191 on ClinicalTrials.gov