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

Information source: Kyunghee University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Stable Angina

Intervention: Clopidogrel, cilostazol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kyunghee University Medical Center

Official(s) and/or principal investigator(s):
Weon Kim, MD, PhD, Principal Investigator, Affiliation: Kyung Hee University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: The differences of platelet aggregation according to the anti-platelet therapy.

Secondary outcome: Changes of platelet activation markers according to the anti-platelet therapy

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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Kyung Hee University, Seoul 130-702, Korea, Republic of
Additional Information

Kyung Hee University Institutional Ethics Committee

Starting date: September 2009
Last updated: April 1, 2011

Page last updated: August 23, 2015

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