Trial Search Results
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access
The Objectives of this study are:
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).
Stanford is currently accepting patients for this trial.
Collaborator: Merck Sharp & Dohme Corp.
- Drug: Vorapaxar sulfate
- Drug: Placebo
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
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
4. Indication or ongoing therapy with anticoagulants, including warfarin, low molecular
weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study