Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease (CKD)

April 1, 2011 updated by: Kyunghee University Medical Center

Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel

Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.

Study Type

Interventional

Enrollment (Actual)

85

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

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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease

Exclusion Criteria:

  • known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
  • concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
  • platelet count <100 x 106/μL
  • hematocrit < 25%
  • liver disease (bilirubin > 2 mg/dl)
  • active bleeding or bleeding diathesis
  • gastrointestinal bleeding within the last 6 months
  • hemodynamic instability
  • acute coronary or cerebrovascular event within 3 months
  • malignancy
  • concomitant use of a cytochrome P450 inhibitor or a non-steroidal anti-inflammatory drug
  • recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: clopidogrel 75 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.
Drug: Clopidogrel, cilostazol
Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
Other Names:
  • Plavix
  • pletaal
ACTIVE_COMPARATOR: clopidogrel 150 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.
Drug: Clopidogrel, cilostazol
Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
Other Names:
  • Plavix
  • pletaal
ACTIVE_COMPARATOR: adjunctive cilostazol
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive co-administration of adjunctive cilostazol (100 mg twice daily) and clopidogrel (75 mg/day; [group 3, 20 patients]) for 14 days.
Drug: Clopidogrel, cilostazol
Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
Other Names:
  • Plavix
  • pletaal
ACTIVE_COMPARATOR: 75mg clopidogrel
control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
Drug: Clopidogrel, cilostazol
Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
Other Names:
  • Plavix
  • pletaal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differences of platelet aggregation according to the anti-platelet therapy.
Time Frame: 14 days

Platelet function was assessed with light transmittance aggregometry and the VerifyNowTM P2Y12 assay.

High on-treatment platelet reactivity was defined as 5 μmol/L of ADP-induced Aggmax > 50%.

Inhibition of platelet aggregation (IPA) was defined as the percent decrease in aggregation values obtained at baseline and after treatment.

VerifyNow-P2Y12 assay results are also assessed and expressed in P2Y12 reaction units (PRUs) and the percentage of inhibition.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of platelet activation markers according to the anti-platelet therapy
Time Frame: 14 days
Markers of platelet activation (soluble CD40 ligand [sCD40L] and soluble P-selectin [sP-selectin]) were assessed at baseline and after 14 days of anti-platelet therapy.
14 days

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Weon Kim, MD, PhD, Kyunghee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIANO-CKD2

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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