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®)

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: generic clopidogrel (Plavitor® ); Drug: original clopidogrel (Plavix® )

• Registration Number: NCT02060786
• Lead Sponsor: Ajou University School of Medicine

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 Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients with unstable angina or non-ST elevation myocardial infarction
2. Patients who are planned coronary angiography
3. Age >18 years, <75 years
4. Patients who agree to the study protocol

Exclusion Criteria

1. Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
2. Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
3. Allergy to antiplatelet agent
4. Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
5. History of drug abuse or alcohol abuse
6. ST elevation myocardial infarction
7. Pregnancy
8. Low platelet count (< 100,000 /L) or abnormal results of PT or PTT
9. Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU)
10. Renal failure ( Cr > 2.0 mg/dL)
11. Malignancy
12. Proton pump inhibitor, NSAIDs statin (except atorvastatin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
generic Clopidogrel Bisulfate (Plavitor®)	generic clopidogrel (Plavitor® )	generic Clopidogrel Bisulfate (Plavitor®) 600mg loading
original Clopidogrel Bisulfate (Plavix®)	original clopidogrel (Plavix® )	original Clopidogrel Bisulfate (Plavix®) 600mg loading

Primary Outcome Measures

Name	Time	Method
PRU level at 2 hours after clopidogrel loading	2 hours after clopidogrel loading

Secondary Outcome Measures

Name	Time	Method
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading	4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading	2 hours after loading
Composite of death, myocardial infarction, target vessel revascularization	at 30 days
Stent thrombosis by Academic Research Consortium definition	at 30 days
Incidence of TIMI major bleedings	at 30 days

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of