Chronic Kidney Disease
Conditions
Keywords
platelet, ticagrelor, clopidogrel, end stage renal disease, hemodialysis
Brief summary
Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.
Detailed description
Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. One of good option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has been already shown improved clinical outcomes. But little is known the antiplatelet effects of ticagrelor in ESRD patients on HD. The present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with ESRD undergoing maintenance HD.
Interventions
DRUGTicagrelor
After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.
DRUGClopidogrel
After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.
Sponsors
Kyunghee University
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ESRD patients undergoing regular (≥ 6 months) maintenance HD * ongoing (≥ 2 months) treatment with clopidogrel * P2Y12 reaction units (PRUs) were more than 235
Exclusion criteria
* known allergies to aspirin, clopidogrel, or ticagrelor * concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole) * thrombocytopenia (platelet count \<100,000/mm3) * hematocrit \<25% * uncontrolled hyperglycemia (hemoglobin A1c \>10%) * liver disease (bilirubin level \>2 mg/dl) * symptomatic severe pulmonary disease * active bleeding or bleeding diathesis * gastrointestinal bleeding within the last 6 months * hemodynamic instability * acute coronary or cerebrovascular event within the last 3 months * pregnancy * any malignancy * concomitant use of a cytochrome P450 inhibitor or nonsteroidal anti-inflammatory drug * recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of antiplatelet effects assessed by VerifyNow assay | 14 days after study drug treatment | The difference of PRU values achieved following antiplatelet therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of onset and offset of the antiplatelet effects | 14 days after study drugs treatment | the difference of slope during onset and offset of study drugs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | during study period | Adverse events such as bleeding |
Countries
South Korea
Outcome results
None listed