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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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original Clopidogrel Bisulfate (Plavix®)

original Clopidogrel Bisulfate (Plavix®) 600mg loading

Group Type ACTIVE_COMPARATOR

original clopidogrel (Plavix® )

Intervention Type DRUG

generic Clopidogrel Bisulfate (Plavitor®)

generic Clopidogrel Bisulfate (Plavitor®) 600mg loading

Group Type EXPERIMENTAL

generic clopidogrel (Plavitor® )

Intervention Type DRUG

Interventions

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generic clopidogrel (Plavitor® )

Intervention Type DRUG

original clopidogrel (Plavix® )

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No