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ONSET and OFFSET of Ticagrelor in ESRD

Information source: Kyunghee University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: Ticagrelor (Drug); Clopidogrel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kyunghee University Medical Center

Official(s) and/or principal investigator(s):
Weon Kim, MD, PhD, Principal Investigator, Affiliation: Kyung-Hee University Hospital

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.

Clinical Details

Official title: Platelet Reactivity in Patients With End Stage Renal Disease Receiving Clopidogrel Compared With Ticagrelor

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: The difference of antiplatelet effects assessed by VerifyNow assay

Secondary outcome: the rate of onset and offset of the antiplatelet effects

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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Kyung Hee University Hospital, Seoul 130-702, Korea, Republic of
Additional Information

Starting date: January 2013
Last updated: June 12, 2014

Page last updated: August 23, 2015

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