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CompletedNCT01765452Updated May 12, 2014

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

A Phase 4 interventional study of Closone and Plavix with Astrix in Coronary Artery Disease, sponsored by HK inno.N Corporation. Completed at 7 sites in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-05-12.

Sponsored by HK inno.N Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
285
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 285 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
285 participants (actual)

Study arms

  • Experimental
    Closone

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

    Drug: Closone

  • Active comparator
    Plavix with Astrix

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

    Drug: Plavix with Astrix

Interventions

  • DrugClosone

    75mg/100mg, 8weeks, PO

  • DrugPlavix with Astrix

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

06

What researchers measure

Primary outcomes

  1. Change from baselinine in P2Y12% inhibition at week 8

    Time frame: Baseline, week 8

Secondary outcomes

  1. Change from baseline in PRU, ARU at week 8

    Time frame: Baseline, week 8

07

Study locations

7 sites
  • Inje university haeundae paik hospital
    Busan, Korea, Republic of
  • Kosin university gospel hospital
    Busan, Korea, Republic of
  • Pusan national university hospital
    Busan, Korea, Republic of
  • Chungbuk national university hospital
    Chungbuk, Korea, Republic of
  • Dongguk University Medical Center
    Gyeonggi-do, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
  • SNU Boramae Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01765452
Lead sponsor
HK inno.N Corporation
Responsible party
Sponsor
First posted
Jan 10, 2013
Start date
Oct 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
May 12, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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