ONSET and OFFSET of Ticagrelor in ESRD

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02163954
• Lead Sponsor: Kyunghee University Medical Center

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-16
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Ticagrelor	Patients treated with clopidogrel for 14 days
Clopidogrel	Clopidogrel	Patients treated with clopidogrel for 14 days
Ticagrelor	Clopidogrel	Patients treated with ticagrelor for 14 days
Ticagrelor	Ticagrelor	Patients treated with ticagrelor 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 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

Trial Locations

Locations (1)

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of