Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access

Objectives:

1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional
maturation when administered during the maturation process compared with placebo.

2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary
procedures to aid in fistula maturation compared with placebo.

3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for
hemodialysis compared with placebo.

This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be
conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will
be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health
Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The
investigators expect to enroll 128 patients. Patients will be assigned to treatment groups
with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.
Patients will be stratified based on fistula location (lower arm versus upper arm).

Participation in this study will not affect standard care of patients with AV fistulae
receiving hemodialysis. The only additional treatment is administration of the study drug or
placebo and additional monitoring, including one additional ultrasound, for 6 months.

Inclusion Criteria:

1. Age >18

2. Receiving or planning to receive maintenance hemodialysis

3. Ability to sign informed consent

4. 3 mm venous diameter within recipient vein

Exclusion Criteria:

1. History of stroke, transient ischemic attack or intracranial hemorrhage

2. History of or high level of suspicion for, severe arterial insufficiency of the hand

3. Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg
daily

4. Indication or ongoing therapy with anticoagulants, including warfarin, low molecular
weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.