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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Closone
Plavix with Astrix
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closone

Plavix with Astrix

Arm Description

75mg/100mg per day, 4weeks, PO

Plavix 75mg with Astrix 100mg, 4weeks, PO

Outcomes

Primary Outcome Measures

Change from baseline in P2Y12% inhibition at week 4

Secondary Outcome Measures

Change from baseline in VerifyNow P2Y12 reaction unit at week 4
PRU : VerifyNow P2Y12 reaction unit
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4
ARU : VerifyNow Aspirin Reaction Unit
Change from baseline in maxymal platelet aggregation at week 4
MPA : maxymal platelet aggregation

Full Information

First Posted
January 7, 2013
Last Updated
February 28, 2015
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01763749
Brief Title
Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closone
Arm Type
Experimental
Arm Description
75mg/100mg per day, 4weeks, PO
Arm Title
Plavix with Astrix
Arm Type
Active Comparator
Arm Description
Plavix 75mg with Astrix 100mg, 4weeks, PO
Intervention Type
Drug
Intervention Name(s)
Closone
Intervention Description
Closone 75mg/100mg, 4weeks, PO
Intervention Type
Drug
Intervention Name(s)
Plavix with Astrix
Intervention Description
Plavix 75mg with Astrix 100mg, 4weeks, PO
Primary Outcome Measure Information:
Title
Change from baseline in P2Y12% inhibition at week 4
Time Frame
Baseline, week 4
Secondary Outcome Measure Information:
Title
Change from baseline in VerifyNow P2Y12 reaction unit at week 4
Description
PRU : VerifyNow P2Y12 reaction unit
Time Frame
Baseline, week 4
Title
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4
Description
ARU : VerifyNow Aspirin Reaction Unit
Time Frame
Baseline, week 4
Title
Change from baseline in maxymal platelet aggregation at week 4
Description
MPA : maxymal platelet aggregation
Time Frame
Baseline, week 4
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
Baseline, week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Bae Seung, MD, PhD
Organizational Affiliation
Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital
City
Seoul
State/Province
Seochogu
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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