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

Jeil Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: ANEURYSM CORONARY ARTERY

Treatments: Drug: Clopidogrel-Aspirin(co-administration) 1; Drug: Clopirin 1; Drug: Clopidogrel-Aspirin(co-administration) 2; Drug: Clopirin 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410083

JP_CLN_01

Details and patient eligibility

About

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.

Enrollment: 448 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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448 participants in 4 patient groups

Clopirin 1

Experimental group

Description:

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

Treatment:

Drug: Clopirin 1

Clopidogrel/Aspirin co-administration 1

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel-Aspirin(co-administration) 1

Clopirin 2

Experimental group

Description:

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

Treatment:

Drug: Clopirin 2

Clopidogrel/Aspirin co-administration 2

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel-Aspirin(co-administration) 2