Comparison of the Efficacy and Safety of Closone and Clop... | NCT01763749

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

NCT01763749

Sponsor

Seoul St. Mary's Hospital

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

91Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Closone
Plavix with Astrix

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 7, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Closone	Experimental	75mg/100mg per day, 4weeks, PO	Drug: Closone
Plavix with Astrix	Active Comparator	Plavix 75mg with Astrix 100mg, 4weeks, PO	Drug: Plavix with Astrix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closone	Drug	Closone 75mg/100mg, 4weeks, PO	Closone
Plavix with Astrix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in P2Y12% inhibition at week 4		Baseline, week 4

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in VerifyNow P2Y12 reaction unit at week 4	PRU : VerifyNow P2Y12 reaction unit	Baseline, week 4
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4	ARU : VerifyNow Aspirin Reaction Unit

Other Outcomes

Measure	Description	Time Frame
Adverse events		Baseline, week 4

Eligibility Module

Eligibility Criteria

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 Ⅳ)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds