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

Chronic Kidney Disease Clinical Trial

— CKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328470
• Other study ID #: PIANO-CKD2
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2011
• Last updated: April 1, 2011
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2009
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stable Angina

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Angiolillo DJ, Bernardo E, Capodanno D, Vivas D, Sabaté 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 — View 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 Opti — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences of platelet aggregation according to the anti-platelet therapy.	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	Yes
Secondary	Changes of platelet activation markers according to the anti-platelet therapy	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	Yes

External Links

•   Korea Food and Drug Administration
•   Kyung Hee University Institutional Ethics Committee