Clinical trial NCT01328470: Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
Official title: Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Stable Angina
Keywords: platelet
cilostazol
clopidogrel
chronic kidney disease
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2011-04-04
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: The differences of platelet aggregation according to the anti-platelet therapy.
timeFrame: 14 days
Secondary outcomes:
measure: Changes of platelet activation markers according to the anti-platelet therapy
timeFrame: 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University
Study officials:
affiliation: Kyunghee University
name: Weon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SH, Kim W, Park CS, Kang WY, Hwang SH, Kim W. A comparison of clopidogrel responsiveness in patients with versus without chronic renal failure. Am J Cardiol. 2009 Nov 1;104(9):1292-5. doi: 10.1016/j.amjcard.2009.06.049.
citation: Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
citation: Angiolillo DJ, Bernardo E, Capodanno D, Vivas D, Sabate M, Ferreiro JL, Ueno M, Jimenez-Quevedo P, Alfonso F, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of chronic kidney disease on platelet function profiles in diabetes mellitus patients with coronary artery disease taking dual antiplatelet therapy. J Am Coll Cardiol. 2010 Mar 16;55(11):1139-46. doi: 10.1016/j.jacc.2009.10.043.
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Woo JS, Kim W, Lee SR, Jung KH, Kim WS, Lew JH, Lee TW, Lim CK. Platelet reactivity in patients with chronic kidney disease receiving adjunctive cilostazol compared with a high-maintenance dose of clopidogrel: results of the effect of platelet inhibition according to clopidogrel dose in patients with chronic kidney disease (PIANO-2 CKD) randomized study. Am Heart J. 2011 Dec;162(6):1018-25. doi: 10.1016/j.ahj.2011.09.003. Epub 2011 Nov 8.