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®)

February 11, 2014 updated by: Seung-Jea Tahk, Ajou University School of Medicine
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: original Clopidogrel Bisulfate (Plavix®)
original Clopidogrel Bisulfate (Plavix®) 600mg loading
Drug: original clopidogrel (Plavix® )
Experimental: generic Clopidogrel Bisulfate (Plavitor®)
generic Clopidogrel Bisulfate (Plavitor®) 600mg loading
Drug: generic clopidogrel (Plavitor® )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PRU level at 2 hours after clopidogrel loading
Time Frame: 2 hours after clopidogrel loading
2 hours after clopidogrel loading

Secondary Outcome Measures

Outcome Measure
Time Frame
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
Time Frame: 4 -, 8- and 24 hours after clopidogrel loading
4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading
Time Frame: 2 hours after loading
2 hours after loading
Composite of death, myocardial infarction, target vessel revascularization
Time Frame: at 30 days
at 30 days
Stent thrombosis by Academic Research Consortium definition
Time Frame: at 30 days
at 30 days
Incidence of TIMI major bleedings
Time Frame: at 30 days
at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Collaborators

Dong-A Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Plavitor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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