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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease (CAD)

Treatments: Drug: Clopidogrel; Drug: aspirin 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830491

HM-CPG-401

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups

Clopidogrel napadisilate

Experimental group

Description:

aspirin 100mg

Treatment:

Drug: Clopidogrel

Drug: aspirin 100mg

clopidogrel bisulfate

Active Comparator group

Description:

aspirin 100mg

Treatment:

Drug: Clopidogrel

Drug: aspirin 100mg