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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Closone
Plavix with Astrix
Sponsored by
HK inno.N Corporation
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 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

Sites / Locations

  • Inje university haeundae paik hospital
  • Kosin university gospel hospital
  • Pusan national university hospital
  • Chungbuk national university hospital
  • Dongguk University Medical Center
  • Seoul National University Hospital
  • SNU Boramae Medical Center

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, 8weeks, PO

75mg per day, 8weeks, PO 100mg per day, 8weeks, PO

Outcomes

Primary Outcome Measures

Change from baselinine in P2Y12% inhibition at week 8

Secondary Outcome Measures

Change from baseline in PRU, ARU at week 8

Full Information

First Posted
January 7, 2013
Last Updated
May 9, 2014
Sponsor
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01765452
Brief Title
Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation

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
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closone
Arm Type
Experimental
Arm Description
75mg/100mg per day, 8weeks, PO
Arm Title
Plavix with Astrix
Arm Type
Active Comparator
Arm Description
75mg per day, 8weeks, PO 100mg per day, 8weeks, PO
Intervention Type
Drug
Intervention Name(s)
Closone
Intervention Description
75mg/100mg, 8weeks, PO
Intervention Type
Drug
Intervention Name(s)
Plavix with Astrix
Intervention Description
75mg, 100mg a day, 8weeks, PO
Primary Outcome Measure Information:
Title
Change from baselinine in P2Y12% inhibition at week 8
Time Frame
Baseline, week 8
Secondary Outcome Measure Information:
Title
Change from baseline in PRU, ARU at week 8
Time Frame
Baseline, week 8

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 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
Facility Information:
Facility Name
Inje university haeundae paik hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kosin university gospel hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan national university hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chungbuk national university hospital
City
Chungbuk
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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