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Phase 2 N=13 Randomized Quadruple-blind Treatment

Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access

AV Fistula

Enrolled (actual)
13
Serious AEs
46.2%
Results posted
Jan 2019
Primary outcome: Primary: Time to AV Fistula Functional Maturation — 169; 145 Days to functional maturation

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Vorapaxar sulfate (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ken Mahaffey
Primary completion
Oct 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to AV Fistula Functional Maturation
169; 145
SECONDARY
Count of Participants With AV Fistula Use
2; 4
SECONDARY
Count Participants With AV Fistula Patency
1; 5
SECONDARY
Count of All Participants With Bleeding Events
0; 1

Summary

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).

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02475837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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