Clinical Trial: Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor
Brief Summary: This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
Detailed Summary:
Sponsor: Ajou University School of Medicine
Current Primary Outcome: PRU level at 2 hours after clopidogrel loading [ Time Frame: 2 hours after clopidogrel loading ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading [ Time Frame: 4 -, 8- and 24 hours after clopidogrel loading ]
- ARU level by VerifyNow before and 2 hours after loading [ Time Frame: 2 hours after loading ]
- Composite of death, myocardial infarction, target vessel revascularization [ Time Frame: at 30 days ]
- Stent thrombosis by Academic Research Consortium definition [ Time Frame: at 30 days ]
- Incidence of TIMI major bleedings [ Time Frame: at 30 days ]
Original Secondary Outcome: Same as current
Information By: Ajou University School of Medicine
Dates:
Date Received: February 11, 2014
Date Started: October 2010
Date Completion:
Last Updated: February 11, 2014
Last Verified: February 2014
