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Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01830491
First received: April 5, 2013
Last updated: April 9, 2013
Last verified: April 2013

April 5, 2013
April 9, 2013
March 2009
August 2009   (final data collection date for primary outcome measure)
the percent inhibition of the platelet aggregation change [ Time Frame: baseline and 4weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01830491 on ClinicalTrials.gov Archive Site
the change of P2Y12 reaction unit (PRU) [ Time Frame: baseline and 4weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial

The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before > 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease (CAD)
  • Drug: Clopidogrel
    Other Names:
    • Pidogul®
    • Plavix®
  • Drug: aspirin 100mg
  • Experimental: Clopidogrel napadisilate
    aspirin 100mg
    Interventions:
    • Drug: Clopidogrel
    • Drug: aspirin 100mg
  • Active Comparator: clopidogrel bisulfate
    aspirin 100mg
    Interventions:
    • Drug: Clopidogrel
    • Drug: aspirin 100mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
December 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 20 to 80 years
  • men and women with coronary artery disease who had been treated with drug-eluting stent placement before > 12 months
  • patients who had remained in a stable condition with a single antiplatelet agent, aspirin
  • patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography

Exclusion Criteria:

  • Patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period
  • Patients who were suffering from drug abuse or alcohol addiction
  • hypersensitivity to clopidogrel or aspirin
  • severe liver disease (ALT or AST ≥ 10 times the upper normal limit)
  • active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage
  • a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding)
  • pregnant or lactating women
  • women with childbearing potential who were not using an appropriate contraception method
  • had medical or mental contra-indications to the study treatment
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01830491
HM-CPG-401
No
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Principal Investigator: Byung-Hee Oh, MD, PhD Seoul National University Hospital
Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP