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

ANEURYSM CORONARY ARTERY Clinical Trial

Official title:

Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410083
• Other study ID #: JP_CLN_01
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2015
• Last updated: March 12, 2017
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: December 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• ANEURYSM CORONARY ARTERY
• Coronary Aneurysm

Intervention

Drug:
• Clopirin 1

• Clopidogrel-Aspirin(co-administration) 1

• Clopirin 2

• Clopidogrel-Aspirin(co-administration) 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% inhibition =?Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU		8 weeks
Secondary	? PRU = Post treatment PRU - Pre treatment PRU		8 weeks
Secondary	? ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU		8 weeks