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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763749
• Other study ID #: CLO_1201
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2013
• Last updated: February 28, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Seoul St. Mary's Hospital
• 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: 91
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 ?)

• 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

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
Closone 75mg/100mg, 4weeks, PO
• Plavix with Astrix
Plavix 75mg with Astrix 100mg, 4weeks, PO

Locations

Country	Name	City	State
Korea, Republic of	Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital	Seoul	Seochogu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		Baseline, week 4	Yes
Primary	Change from baseline in P2Y12% inhibition at week 4		Baseline, week 4	No
Secondary	Change from baseline in VerifyNow P2Y12 reaction unit at week 4	PRU : VerifyNow P2Y12 reaction unit	Baseline, week 4	No
Secondary	Change from baseline in VerifyNow Aspirin Reaction Unit at week 4	ARU : VerifyNow Aspirin Reaction Unit	Baseline, week 4	No
Secondary	Change from baseline in maxymal platelet aggregation at week 4	MPA : maxymal platelet aggregation	Baseline, week 4	No