Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention

The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Closone; Drug: Plavix with Astrix

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Chungbuk, Korea, Republic of
    • Chungbuk National University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Dongguk University Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closone; 75mg/100mg per day, 8weeks, PO	Drug: Closone; 75mg/100mg, 8weeks, PO
Active Comparator: Plavix with Astrix; 75mg per day, 8weeks, PO 100mg per day, 8weeks, PO	Drug: Plavix with Astrix; 75mg, 100mg a day, 8weeks, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baselinine in P2Y12% inhibition at week 8	Baseline, week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in PRU, ARU at week 8	Baseline, week 8

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 9, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: CJ_CLO_401