Platelet Reactivity in Patients With Chronic Kidney Disease Receiving Adjunctive Cilostazol Compared to a High-maintenance Dose of Clopidogrel
Overview
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- The differences of platelet aggregation according to the anti-platelet therapy.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
clopidogrel 75 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days.
Intervention: Clopidogrel, cilostazol (Drug)
clopidogrel 150 mg/day
CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days.
Intervention: Clopidogrel, cilostazol (Drug)
adjunctive cilostazol
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.
Intervention: Clopidogrel, cilostazol (Drug)
75mg clopidogrel
control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
Intervention: Clopidogrel, cilostazol (Drug)
Outcomes
Primary Outcomes
The differences of platelet aggregation according to the anti-platelet therapy.
Time Frame: 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 Outcomes
- Changes of platelet activation markers according to the anti-platelet therapy(14 days)