Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
Primary Purpose
Coronary Artery Disease (CAD)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clopidogrel
aspirin 100mg
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease (CAD)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clopidogrel napadisilate
clopidogrel bisulfate
Arm Description
aspirin 100mg
aspirin 100mg
Outcomes
Primary Outcome Measures
the percent inhibition of the platelet aggregation change
Secondary Outcome Measures
the change of P2Y12 reaction unit (PRU)
Full Information
NCT ID
NCT01830491
First Posted
April 5, 2013
Last Updated
October 10, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01830491
Brief Title
Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel napadisilate
Arm Type
Experimental
Arm Description
aspirin 100mg
Arm Title
clopidogrel bisulfate
Arm Type
Active Comparator
Arm Description
aspirin 100mg
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Pidogul®, Plavix®
Intervention Type
Drug
Intervention Name(s)
aspirin 100mg
Primary Outcome Measure Information:
Title
the percent inhibition of the platelet aggregation change
Time Frame
baseline and 4weeks
Secondary Outcome Measure Information:
Title
the change of P2Y12 reaction unit (PRU)
Time Frame
baseline and 4weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Hee Oh, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23913405
Citation
Lee S, Lee HY, Park KW, Kang HJ, Koo BK, Kim HS, Choi DJ, Kim MA, Oh BH. Comparison of antiplatelet effect and safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients: multi-center, randomized, double-blind, phase IV, non-inferiority clinical trial. Am J Cardiovasc Drugs. 2013 Dec;13(6):413-24. doi: 10.1007/s40256-013-0039-y.
Results Reference
derived
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Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
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