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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: Clopidogrel
Drug: aspirin 100mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • the percent inhibition of the platelet aggregation change [ Time Frame: baseline and 4weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change of P2Y12 reaction unit (PRU) [ Time Frame: baseline and 4weeks ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel napadisilate
aspirin 100mg
Drug: Clopidogrel
Other Names:
  • Pidogul®
  • Plavix®
Drug: aspirin 100mg
Active Comparator: clopidogrel bisulfate
aspirin 100mg
Drug: Clopidogrel
Other Names:
  • Pidogul®
  • Plavix®
Drug: aspirin 100mg

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01830491

Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Byung-Hee Oh, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01830491     History of Changes
Other Study ID Numbers: HM-CPG-401
Study First Received: April 5, 2013
Last Updated: April 9, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on October 19, 2014