Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access

Completed · Phase 2 · Has a placebo group

Conditions studied: AV Fistula

In brief

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).

Key facts

Study ID

NCT02475837

Run by

Ken Mahaffey

People needed

17

Starts

2015-08-26

Expected to finish

2017-10-23

Last updated by the study team

2019-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18
• Receiving or planning to receive maintenance hemodialysis
• Ability to sign informed consent
• 3 mm venous diameter within recipient vein

You may not qualify if…

• History of stroke, transient ischemic attack or intracranial hemorrhage
• History of or high level of suspicion for, severe arterial insufficiency of the hand
• Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg daily
• Indication or ongoing therapy with anticoagulants, including warfarin, low molecular weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.

Where it is running

• Stanford Univeristy — Stanford, California, United States

Full record on ClinicalTrials.gov

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