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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01830491

Enrollment

162

Registered

2013-04-12

Start date

2009-03-31

Completion date

2009-12-31

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

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.

Interventions

DRUGClopidogrel

DRUGaspirin 100mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
the percent inhibition of the platelet aggregation change	baseline and 4weeks

Secondary

Measure	Time frame
the change of P2Y12 reaction unit (PRU)	baseline and 4weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026