The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol (4C-DES)

February 11, 2009 updated by: Samsung Medical Center

The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation

To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
  • Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)

Exclusion Criteria:

  • Acute myocardial infarction within 2 weeks
  • Unstable angina within 2 weeks
  • History of using glycoprotein IIb/IIIa inhibitor within 1 month
  • Cerebral infarction within 3 months
  • Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL)
  • history of gastrointestinal bleeding or genitourinary bleeding within 3 months
  • needed oral anticoagulation
  • aspirin, clopidogrel or cilostazol hypersensitivity
  • congestive heart failure
  • serum creatinine level >2mg/dl
  • malignancy
  • using cytochrome P450 inhibitor (eg, itraconazole)

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: A
Aspirin plus increasing clopidogrel group
Drug: aspirin, clopidogrel
aspirin 100 mg plus clopidogrel 150mg qd
Experimental: B
Aspirin, clopidogrel plus cilostazol group
Drug: aspirin, clopidogrel, cilostazol
aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
P2Y12 reaction unit (PRU)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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

February 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 27, 2008

First Submitted That Met QC Criteria

February 10, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-12-026

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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