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

NCT01830491 | Completed Phase 4

• 1 other identifier: HM-CPG-401
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• the percent inhibition of the platelet aggregation change

  baseline and 4weeks

Secondary Outcomes (1)

• the change of P2Y12 reaction unit (PRU)

  baseline and 4weeks

Study Arms (2)

Clopidogrel napadisilate

EXPERIMENTAL

aspirin 100mg

Drug: Clopidogrel; Drug: aspirin 100mg

clopidogrel bisulfate

ACTIVE COMPARATOR

aspirin 100mg

Drug: Clopidogrel; Drug: aspirin 100mg

Interventions

Clopidogrel DRUG

Also known as: Pidogul®, Plavix®

Clopidogrel napadisilate; clopidogrel bisulfate

aspirin 100mg DRUG

Clopidogrel napadisilate; clopidogrel bisulfate

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Related Publications (1)

• 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.

  PMID: 23913405 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Byung-Hee Oh, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 12, 2013
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share