Clopidogrel High Dose Evaluation for the Patient With Cor... | NCT01069302

Studies
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan

NCT01069302

Sponsor

Takeshi Morimoto

Status

Completed

Last Update Posted

Jan 11, 2016Estimated

Enrollment

106Actual

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Clopidogrel
Clopidogrel
Clopidogrel
Clopidogrel

Countries

Japan

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

Jan 2016

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

Feb 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

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

Jan 7, 2016

Last Update Posted Date

Jan 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.

Detailed Description

Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.

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

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High loading and high maintenance	Active Comparator	Clopidogrel loading 600mg and maintenance 150mg for 7days	Drug: Clopidogrel
High loading and low maintenance	Active Comparator	Clopidogrel loading 600mg and maintenance 75mg for 7days	Drug: Clopidogrel
Low loading and high maintenance	Active Comparator	Clopidogrel loading 300mg and maintenance 150mg for 7days	Drug: Clopidogrel
Low loading and low maintenance	Active Comparator	Clopidogrel loading 300mg and maintenance 75mg for 7days	Drug: Clopidogrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clopidogrel	Drug	Clopidogrel loading 600mg and maintenance 150mg for 7days	High loading and high maintenance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inhibition of platelet aggregation 24 hours after loading		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Inhibition of platelet aggregation 7 days after loading		7 days
Inhibition of platelet aggregation 28 days after loading		28 days
all cause death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for percutaneous coronary intervention due to ischemic heart disease
Patients taking aspirin 81-100mg at least 1 week.

Exclusion Criteria:

Patients with ST elevation myocardial infarction
Patients have contraindication of aspirin or clopidogrel
Patients taking warfarin
Patients received thrombolytic therapy within 2 weeks
Patients taking anti-platelet agents except aspirin within 1 month
Patients taking corticosteroid.
Patients taking proton pump inhibitor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takeshi Kimura, MD	Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Kyoto University Hospital		Kyoto	Kyoto	606-8507	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided