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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765452

Enrollment

285

Registered

2013-01-10

Start date

2012-10-31

Completion date

2013-08-31

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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

Interventions

DRUGClosone

75mg/100mg, 8weeks, PO

DRUGPlavix with Astrix

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026