drugset / Trial / NCT02335099

Determine the Safety/Efficacy of Ticagrelor for Maintaining Patency of Arterio-Venous Fistulae Created for Hemodialysis

NCT02335099

Phase 1/2 Completed 54 enrolled University of Virginia AstraZeneca · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is a randomized, placebo-controlled, single blind clinical trial. Seventy patients with ESRD on chronic HD and a functioning AVF will be recruited. The following data will be documented on each patient: 1-Age/gender/race/body weight/cause of ESRD 2-Vintage of HD 3-Time since access was placed 4-Type and place of access and blood flow rate of access 5-History of prior access problems 6-Comorbid conditions (Hypertension, coronary artery disease, Diabetes Mellitus, Bleeding problems, peripheral vascular disease). 7-Current medications (Coumadin, Erythropoiesis stimulating agents, heparin, other antiplatelets, digoxin, statins). Patients will be randomized into two groups to receive: Group 1: Ticagrelor 90 mg PO BID Group 2: Placebo drug PO BID.

Timeline

Start
2014-12
Primary completion
2019-06
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ticagrelor Small molecule 90 mg Oral