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

Information source: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ANEURYSM CORONARY ARTERY

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

Phase: Phase 4

Status: Completed

Sponsored by: Jeil Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Hyo-soo Kim, Professor, Principal Investigator, Affiliation: Seoul National University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU

Secondary outcome:

△ PRU = Post treatment PRU - Pre treatment PRU

△ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU

Eligibility

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: November 2012
Last updated: April 1, 2015

Page last updated: August 23, 2015

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