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

Phase 4

Completed

• Conditions: ANEURYSM CORONARY ARTERY
• Interventions: Drug: Clopirin 1; Drug: Clopidogrel-Aspirin(co-administration) 1; Drug: Clopirin 2; Drug: Clopidogrel-Aspirin(co-administration) 2

• Registration Number: NCT02410083
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-04
• Status Verified: 2015-03
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Study Completion: 2015-12
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopirin 1	Clopirin 1	Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.
Clopidogrel/Aspirin co-administration 1	Clopidogrel-Aspirin(co-administration) 1	Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.
Clopirin 2	Clopirin 2	Clopirin single-administration. Before this clinical trial Aspirin single-administration.
Clopidogrel/Aspirin co-administration 2	Clopidogrel-Aspirin(co-administration) 2	Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.

Primary Outcome Measures

Name	Time	Method
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU	8 weeks

Secondary Outcome Measures

Name	Time	Method
△ PRU = Post treatment PRU - Pre treatment PRU	8 weeks
△ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU	8 weeks