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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765452
• Other study ID #: CJ_CLO_401
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2013
• Last updated: May 9, 2014
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Closone
75mg/100mg, 8weeks, PO
• Plavix with Astrix
75mg, 100mg a day, 8weeks, PO

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baselinine in P2Y12% inhibition at week 8		Baseline, week 8	No
Secondary	Change from baseline in PRU, ARU at week 8		Baseline, week 8	No