Chronic Kidney Disease, Stable Angina
Conditions
Keywords
platelet, cilostazol, clopidogrel, chronic kidney disease
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.
Interventions
DRUGClopidogrel, 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
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The differences of platelet aggregation according to the anti-platelet therapy. | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of platelet activation markers according to the anti-platelet therapy | 14 days | 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. |
Countries
South Korea
Outcome results
None listed