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®)

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Collaborators: Dong-A Pharmaceutical; Dong-A Pharmaceutical Corporation
• Treatments: Clopidogrel; Ticlopidine

Criteria

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)