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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®)

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060786
Enrollment
90
Registered
2014-02-12
Start date
2010-10-31
Completion date
2013-06-30
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Antiplatelet; clopidogrel; acute coronary syndrome

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.

Interventions

DRUGgeneric clopidogrel (Plavitor® )
DRUGoriginal clopidogrel (Plavix® )

Sponsors

Dong-A Pharmaceutical
CollaboratorINDUSTRY
Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
PRU level at 2 hours after clopidogrel loading2 hours after clopidogrel loading

Secondary

MeasureTime frame
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading2 hours after loading
Composite of death, myocardial infarction, target vessel revascularizationat 30 days
Stent thrombosis by Academic Research Consortium definitionat 30 days
Incidence of TIMI major bleedingsat 30 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026