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

Kyung Hee University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Stable Angina

Treatments: Drug: Clopidogrel, cilostazol

Study type: Interventional

Funder types: Other

Identifiers

NCT01328470

PIANO-CKD2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 4 patient groups

clopidogrel 75 mg/day

Active Comparator group

Description:

CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.

Treatment:

Drug: Clopidogrel, cilostazol

clopidogrel 150 mg/day

Active Comparator group

Description:

CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.

Treatment:

Drug: Clopidogrel, cilostazol

adjunctive cilostazol

Active Comparator group

Description:

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.

Treatment:

Drug: Clopidogrel, cilostazol

75mg clopidogrel

Active Comparator group

Description:

control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).

Treatment:

Drug: Clopidogrel, cilostazol