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

Last updated: April 1, 2011
Sponsor: Kyunghee University Medical Center
Overall Status: Completed

Phase

4

Condition

Kidney Failure

Myocardial Ischemia

Angina

Treatment

N/A

Clinical Study ID

NCT01328470
PIANO-CKD2
  • Ages 20-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CKD patients undergoing chronic hemodialysis and PCI for stable coronary arterydisease

Exclusion

Exclusion Criteria:

  • known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use beforeenrollment

  • 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-inflammatorydrug

  • recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist.

Study Design

Total Participants: 85
Study Start date:
September 01, 2009
Estimated Completion Date:
August 31, 2010

Study 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.

Connect with a study center

  • Kyung Hee University

    Seoul, 130-702
    Korea, Republic of

    Site Not Available

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