Completed

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

What is being tested

Clopidogrel

+ aspirin 100mg

+ Clopidogrel

Drug

Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 20 to 80 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: March 2009

See protocol details

Summary

Principal SponsorHanmi Pharmaceutical Company Limited

Last updated: October 12, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01830491

Principal SponsorHanmi Pharmaceutical Company Limited

Last updated: October 12, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery Disease

Criteria

4 inclusion criteria required to participate

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 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

patients who had remained in a stable condition with a single antiplatelet agent, aspirin

9 exclusion criteria prevent from participating

Patients who were suffering from drug abuse or alcohol addiction

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

a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding)

active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

aspirin 100mg

Group II

Active Comparator

aspirin 100mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers