Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone
- Registration Number
- NCT01765452
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
Inclusion Criteria
- Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
- 20~86 years old
- Willing to adhere to protocol requirements and sign a informed consent form
Exclusion Criteria
- Subject who did not undergo or failed Drug-Stent Implantation
- Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
- Subjects with a history of substance or alchol abuse
- Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
- Subjects having Aspirin or other NSAIDs-induced Asthma or history
- Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal)
- Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal)
- Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
- Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
- subjects who are pregnant, breastfeeding
- Subjects not using medically acceptable birth control
- Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
- Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Closone Closone 75mg/100mg per day, 8weeks, PO Plavix with Astrix Plavix with Astrix 75mg per day, 8weeks, PO 100mg per day, 8weeks, PO
- Primary Outcome Measures
Name Time Method Change from baselinine in P2Y12% inhibition at week 8 Baseline, week 8
- Secondary Outcome Measures
Name Time Method Change from baseline in PRU, ARU at week 8 Baseline, week 8
Trial Locations
- Locations (7)
Kosin university gospel hospital
🇰🇷Busan, Korea, Republic of
Chungbuk national university hospital
🇰🇷Chungbuk, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Pusan national university hospital
🇰🇷Busan, Korea, Republic of
SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Dongguk University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Inje university haeundae paik hospital
🇰🇷Busan, Korea, Republic of