Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention

October 13, 2009 updated by: Shenyang Northern Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Northern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: optimal antiplatelet
cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance
Drug: cilostazol in addition to aspirin and clopidogrel
Active Comparator: standard antiplatelet
aspirin and clopidogrel for all patients
Drug: cilostazol in addition to aspirin and clopidogrel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemorrhage events at 1 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

  • Principal Investigator: Yaling Han, M.D., Shenyang Northern Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH-2006-C001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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