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Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Primary Purpose

Ischemic Heart Disease, Acute Coronary Syndromes

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

cilostazol in addition to aspirin and clopidogrel

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, platelet function, aspirin, clopidogrel, cilostazol

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

optimal antiplatelet

standard antiplatelet

Arm Description

cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance

aspirin and clopidogrel for all patients

Outcomes

Primary Outcome Measures

Major adverse cardiac and cerebral events at 1 year

Secondary Outcome Measures

Hemorrhage events at 1 year

Full Information

NCT ID

NCT00404781

First Posted

November 28, 2006

Last Updated

October 13, 2009

Sponsor

Shenyang Northern Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00404781

Brief Title

Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

Official Title

Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease, Acute Coronary Syndromes

Keywords

ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, platelet function, aspirin, clopidogrel, cilostazol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

305 (Actual)

8. Arms, Groups, and Interventions

Arm Title

optimal antiplatelet

Arm Type

Experimental

Arm Description

cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance

Arm Title

standard antiplatelet

Arm Type

Active Comparator

Arm Description

aspirin and clopidogrel for all patients

Intervention Type

Drug

Intervention Name(s)

cilostazol in addition to aspirin and clopidogrel

Primary Outcome Measure Information:

Title

Major adverse cardiac and cerebral events at 1 year

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Hemorrhage events at 1 year

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaling Han, M.D.

Organizational Affiliation

Shenyang Northern Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northern Hospital

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110016

Country

China

12. IPD Sharing Statement

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Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

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