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OpenTrials
Completed

NCT Number: NCT02060786

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®)

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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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Hospital

Suwon, 443-720, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unstable angina or non-ST elevation myocardial infarction
  • Patients who are planned coronary angiography
  • Age >18 years, <75 years
  • Patients who agree to the study protocol

Exclusion criteria

  • Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
  • Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
  • Allergy to antiplatelet agent
  • Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
  • History of drug abuse or alcohol abuse
  • ST elevation myocardial infarction
  • Pregnancy
  • Low platelet count (< 100,000 /L) or abnormal results of PT or PTT
  • Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU)
  • Renal failure ( Cr > 2.0 mg/dL)
  • Malignancy
  • Proton pump inhibitor, NSAIDs statin (except atorvastatin)

Treatment and study plan

generic clopidogrel (Plavitor® )

Drug

original clopidogrel (Plavix® )

Drug

Primary outcomes

  1. PRU level at 2 hours after clopidogrel loading

    Time frame: 2 hours after clopidogrel loading

Secondary outcomes

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

    Time frame: 4 -, 8- and 24 hours after clopidogrel loading

  2. ARU level by VerifyNow before and 2 hours after loading

    Time frame: 2 hours after loading

  3. Composite of death, myocardial infarction, target vessel revascularization

    Time frame: at 30 days

  4. Stent thrombosis by Academic Research Consortium definition

    Time frame: at 30 days

  5. Incidence of TIMI major bleedings

    Time frame: at 30 days

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Dong-A Pharmaceutical

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 12, 2014
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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