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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®)

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Corporation
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT02060786
First received: February 11, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: generic clopidogrel (Plavitor® )
Drug: original clopidogrel (Plavix® )
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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®)

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • PRU level at 2 hours after clopidogrel loading [ Time Frame: 2 hours after clopidogrel loading ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading [ Time Frame: 4 -, 8- and 24 hours after clopidogrel loading ] [ Designated as safety issue: No ]
  • ARU level by VerifyNow before and 2 hours after loading [ Time Frame: 2 hours after loading ] [ Designated as safety issue: No ]
  • Composite of death, myocardial infarction, target vessel revascularization [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Stent thrombosis by Academic Research Consortium definition [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of TIMI major bleedings [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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® )

  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060786

Locations
Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of, 443-720
Sponsors and Collaborators
Ajou University School of Medicine
Dong-A Pharmaceutical Corporation
  More Information

No publications provided

Responsible Party: Seung-Jea Tahk, MD,PhD, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02060786     History of Changes
Other Study ID Numbers: Plavitor
Study First Received: February 11, 2014
Last Updated: February 11, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
Antiplatelet; clopidogrel; acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Clopidogrel
Ticlopidine
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014