Status:
COMPLETED
Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 effectiven...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01830491
Start Date
March 1 2009
End Date
December 1 2009
Last Update
October 12 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.