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 not accepting patients for this trial.

Lead Sponsor:

Ken Mahaffey

Collaborator: Merck Sharp & Dohme Corp.

Stanford Investigator(s):

Intervention(s):

  • Drug: Vorapaxar sulfate
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lori McDonnell
650.703.3639
Recruiting