Overview

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

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Virginia
Collaborator:
AstraZeneca
Treatments:
Ticagrelor
Criteria
Inclusion Criteria:

- Patients on chronic hemodialysis with a functioning arterio-venous fistula

Exclusion Criteria:

- Recent history of bleeding over the last 3 months preceding enrollment

- History of bleeding disorder (hemophilia, Von Willebrandt disease, etc….)

- Recent history of blood transfusion over the last 3 months preceding enrollment

- Recent serious injury or surgery over the last 3 months preceding enrollment

- History of gastro-intestinal ulcers

- Moderate-severe hepatic impairment

- Uncontrolled blood pressure (SBP> 200 or DBP >110) post dialysis

- History of stroke

- Pregnant females-self reported

- Hypersensitivity to Aspirin /antiplatelets

- Subjects using peroral anticoagulants