DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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®)

Information source: Ajou University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

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

Phase: Phase 4

Status: Completed

Sponsored by: Ajou University School of Medicine

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.

Clinical Details

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)

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

Primary outcome: PRU level at 2 hours after clopidogrel loading

Secondary outcome:

PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading

ARU level by VerifyNow before and 2 hours after loading

Composite of death, myocardial infarction, target vessel revascularization

Stent thrombosis by Academic Research Consortium definition

Incidence of TIMI major bleedings

Eligibility

Minimum age: 19 Years. Maximum age: 74 Years. Gender(s): Both.

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)

Locations and Contacts

Ajou University Hospital, Suwon 443-720, Korea, Republic of
Additional Information

Starting date: October 2010
Last updated: February 11, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017