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