Effects of Optimized Antiplatelet Treatment After Percuta... | NCT00404781

Studies
Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

NCT00404781

Sponsor

Shenyang Northern Hospital

Status

Completed

Last Update Posted

Oct 14, 2009Estimated

Enrollment

305Actual

Phase

Phase 4

Conditions

Ischemic Heart Disease
Acute Coronary Syndromes

Interventions

cilostazol in addition to aspirin and clopidogrel

Countries

China

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

Oct 2009

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

Jun 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Nov 28, 2006

First Submission Date that Met QC Criteria

Nov 28, 2006

First Posted Date

Nov 29, 2006Estimated

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

Oct 13, 2009

Last Update Posted Date

Oct 14, 2009Estimated

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

Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.

Detailed Description

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

305Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
optimal antiplatelet	Experimental	cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance	Drug: cilostazol in addition to aspirin and clopidogrel
standard antiplatelet	Active Comparator	aspirin and clopidogrel for all patients	Drug: cilostazol in addition to aspirin and clopidogrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cilostazol in addition to aspirin and clopidogrel	Drug		optimal antiplatelet standard antiplatelet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiac and cerebral events at 1 year		1 year

Secondary Outcomes

Measure	Description	Time Frame
Hemorrhage events at 1 year		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non-ST-segment elevated acute coronary syndromes
patients undergoing selective or emergent PCI

Exclusion Criteria:

administration of clopidogrel or ticlopidine within 2 weeks
ST-segment elevated myocardial infarction
contraindications of antiplatelet therapy
history of intracranial bleeding
known bleeding disorders
severe liver or kidney disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yaling Han, M.D.	Shenyang Northern Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Hospital		Shenyang	Liaoning	110016	China

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077407	Cilostazol
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided