Clinical trial NCT01830491: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease (CAD)
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: the percent inhibition of the platelet aggregation change
timeFrame: baseline and 4weeks
Secondary outcomes:
measure: the change of P2Y12 reaction unit (PRU)
timeFrame: baseline and 4weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Byung-Hee Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.