Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

NCT ID: NCT02410083

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.

Conditions

ANEURYSM CORONARY ARTERY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopirin 1

Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.

Group Type: EXPERIMENTAL

Clopirin 1

Intervention Type: DRUG

Clopidogrel/Aspirin co-administration 1

Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.

Group Type: ACTIVE_COMPARATOR

Clopidogrel-Aspirin(co-administration) 1

Intervention Type: DRUG

Clopirin 2

Clopirin single-administration. Before this clinical trial Aspirin single-administration.

Group Type: EXPERIMENTAL

Clopirin 2

Intervention Type: DRUG

Clopidogrel/Aspirin co-administration 2

Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.

Group Type: ACTIVE_COMPARATOR

Clopidogrel-Aspirin(co-administration) 2

Intervention Type: DRUG

Interventions

Clopirin 1

Intervention Type: DRUG

Clopidogrel-Aspirin(co-administration) 1

Intervention Type: DRUG

Clopirin 2

Intervention Type: DRUG

Clopidogrel-Aspirin(co-administration) 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
• Korean men and women between the age of 20 and 85
• Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.

Exclusion Criteria

• Patients who were not treated with PCI or intended to treat with PCI but failed.
• Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
• Patients who had a history of alcohol abuse or intoxication.
• Patients who had hypersensitivity to clopidogrel or aspirin.
• Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
• Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
• Patients who were pregnant, breastfeeding.
• Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
• Patients who medically, psychologically had investigational product administration's prohibition.
• Patients who were not participated in this clinical trial decided by other investigators.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyo-soo Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Other Identifiers

JP_CLN_01

Identifier Type: -

Identifier Source: org_study_id