ONSET and OFFSET of Ticagrelor in ESRD

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyunghee University Medical Center
• Collaborator: Kyunghee University
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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