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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease (CAD)

Intervention: Clopidogrel (Drug); aspirin 100mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Official(s) and/or principal investigator(s):
Byung-Hee Oh, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

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.

Clinical Details

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

Primary outcome: the percent inhibition of the platelet aggregation change

Secondary outcome: the change of P2Y12 reaction unit (PRU)

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2009
Last updated: April 9, 2013

Page last updated: August 23, 2015

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