Ticagrelor and Anti-inflammatory Effects
- Registration Number
- NCT02406911
- Lead Sponsor
- Kyunghee University Medical Center
- Brief Summary
Antiplatelet treatment in patients with end stage renal disease (ESRD) on hemodialysis (HD) is still challenging because of bleeding and thrombotic complications. The investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose 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. 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. The investigators recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with ESRD on HD. However, few studies have been conducted whether platelet reactivity during ticagrelor treatment is associated with endothelial function, platelet activation markers and inflammation status in ESRD patients on HD. Additionally, the dose dependent effects of ticagrelor have been rarely evaluated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- ESRD patients undergoing regular (≥ 6 months) maintenance HD
- ongoing (≥ 2 months) treatment with clopidogrel
- P2Y12 reaction units (PRUs) were more than 235
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ticagrelor 180 mg Ticagrelor After randomization, an initial loading dose of ticagrelor (180 mg) was given and usual dose ticagrelor (ticagrelor 90 mg twice a day) was treated for 14 days. Ticagrelor 90 mg Ticagrelor After randomization, an initial loading dose of ticagrelor (180 mg) was given and low dose ticagrelor (ticagrelor 90 mg once a day) was treated for 14 days.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The difference of antiplatelet effects assessed by light aggregometry assay 14 days after study drug treatment The difference of IPA values achieved following antiplatelet therapy
The difference of endothelial function assessed by forearm flow-mediated vasodilation (FMD) and peripheral arterial tonometry (PAT) 14 days after study drug treatment The difference of endothelial functions achieved following antiplatelet therapy
The difference of anti-inflammatory biomarkers 14 days after study drug treatment The difference of hsCRP, CD40, P-selectin, and IL-6
Trial Locations
- Locations (1)
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of