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®)

Acute Coronary Syndrome Clinical Trial

Official title:

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060786
• Other study ID #: Plavitor
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2014
• Last updated: February 11, 2014
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• generic clopidogrel (Plavitor® )

• original clopidogrel (Plavix® )

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Dong-A Pharmaceutical Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRU level at 2 hours after clopidogrel loading		2 hours after clopidogrel loading	No
Secondary	PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading		4 -, 8- and 24 hours after clopidogrel loading	No
Secondary	ARU level by VerifyNow before and 2 hours after loading		2 hours after loading	No
Secondary	Composite of death, myocardial infarction, target vessel revascularization		at 30 days	Yes
Secondary	Stent thrombosis by Academic Research Consortium definition		at 30 days	Yes
Secondary	Incidence of TIMI major bleedings		at 30 days	Yes