Ticagrelor and Anti-inflammatory Effects

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Kyunghee University Medical Center
• Treatments: Adenosine; Anti-Inflammatory Agents; Ticagrelor

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