Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin

Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)

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): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seochogu
    • Seoul, Seochogu, Korea, Republic of, 137-701
      • Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital

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 condition after Post-Percutaneous Coronary Artery Intervention over twelve months
• 20~85 years old
• Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

• Subject who did not undergo or failed Stent Implantation
• Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
• Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
• Subjects with uncontrolled severe hypertension

• Subjects with high risk of hemorrhage like blood coagulation disorders

  :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage

• Subjects with intractable arrhythmia, intracranial hemorrhage
• Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
• Subjects with Severe hepatopathy(AST and ALT > 10 times the upper limit of normal)
• Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
• Subjects considered as unsuitable based on medical judgement by investigators

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, 4weeks, PO	Drug: Closone; Closone 75mg/100mg, 4weeks, PO
Active Comparator: Plavix with Astrix; Plavix 75mg with Astrix 100mg, 4weeks, PO	Drug: Plavix with Astrix; Plavix 75mg with Astrix 100mg, 4weeks, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in P2Y12% inhibition at week 4	Baseline, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in VerifyNow P2Y12 reaction unit at week 4	PRU : VerifyNow P2Y12 reaction unit	Baseline, week 4
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4	ARU : VerifyNow Aspirin Reaction Unit	Baseline, week 4
Change from baseline in maxymal platelet aggregation at week 4	MPA : maxymal platelet aggregation	Baseline, week 4

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	Baseline, week 4

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Investigators: Principal Investigator: Ki-Bae Seung, MD, PhD, Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: February 28, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary 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: CLO_1201