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

Coronary Artery Disease (CAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830491
• Other study ID #: HM-CPG-401
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2013
• Last updated: October 10, 2016
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel

• aspirin 100mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent inhibition of the platelet aggregation change		baseline and 4weeks	No
Secondary	the change of P2Y12 reaction unit (PRU)		baseline and 4weeks	No