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®)

Ajou University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: generic clopidogrel (Plavitor® ); Drug: original clopidogrel (Plavix® )

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02060786

Plavitor

Details and patient eligibility

About

This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.

Enrollment: 90 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

original Clopidogrel Bisulfate (Plavix®)

Active Comparator group

Description:

original Clopidogrel Bisulfate (Plavix®) 600mg loading

Treatment:

Drug: original clopidogrel (Plavix® )

generic Clopidogrel Bisulfate (Plavitor®)

Experimental group

Description:

generic Clopidogrel Bisulfate (Plavitor®) 600mg loading

Treatment:

Drug: generic clopidogrel (Plavitor® )