ANEURYSM CORONARY ARTERY
Conditions
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.
Interventions
DRUGClopirin 1
DRUGClopidogrel-Aspirin(co-administration) 1
DRUGClopirin 2
DRUGClopidogrel-Aspirin(co-administration) 2
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| △ PRU = Post treatment PRU - Pre treatment PRU | 8 weeks |
| △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU | 8 weeks |
Outcome results
None listed