Evidence map›Paper›PMID 31774037›Full record

Trial reportThe journal of vascular access2020

A double-blind, randomized, placebo-controlled pilot trial to evaluate safety and efficacy of vorapaxar on arteriovenous fistula maturation.

Christoph B Olivier, Vandana Sundaram, Glenn M Chertow, Sumana Shashidhar, Lori K McDonnell, Victoria Y Ding, Manisha Desai, Kenneth W Mahaffey, Matthew Mell

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of vascular access, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Christoph B OlivierStanford Center for Clinical Research (SCCR), Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.ORCID https://orcid.org/0000-0002-3065-625X
Vandana SundaramQuantitative Sciences Unit, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.
Glenn M ChertowDivision of Nephrology, School of Medicine, Stanford University, Stanford, CA, USA.
Sumana ShashidharStanford Center for Clinical Research (SCCR), Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.
Lori K McDonnellDivision of Vascular Surgery, School of Medicine, Stanford University, Stanford, CA, USA.
Victoria Y DingQuantitative Sciences Unit, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.
Manisha DesaiQuantitative Sciences Unit, Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.
Kenneth W MahaffeyStanford Center for Clinical Research (SCCR), Department of Medicine, School of Medicine, Stanford University, Stanford, CA, USA.
Matthew MellDivision of Vascular Surgery, School of Medicine, Stanford University, Stanford, CA, USA.
Stanford University · USCenter for Clinical Research (United States) · USUniversity of California, Davis · USUniversity of Freiburg · DE

Funding

Stanford Islet Research CoreP30DK116074 · NIDDK · STANFORD UNIVERSITY · PI Seung K Kim · 2017 to 2026
$19.5M
NIDDK NIH HHS P30 DK116074
6 · The paper itself

Abstract

backgroundProtease-activated receptor-1 antagonism by vorapaxar could facilitate arteriovenous fistula maturation but may increase bleeding risk.

objectiveThe primary objective of the Vorapaxar Study for Maturation of arteriovenous fistula for Hemodialysis Access (VorapAccess) was to determine if vorapaxar improves arteriovenous fistula functional maturation in patients with end-stage renal disease.

methodsVorapAccess was a randomized, placebo-controlled, double-blind pilot trial comparing 2.5 mg vorapaxar per day with placebo for twelve weeks starting on day two after arteriovenous fistula creation. The primary outcome was time to functional maturation defined as successful cannulation for six hemodialysis sessions within three weeks. The planned sample size was 50 participants. The study was terminated early after withdrawal of planned financial support. Given the small number of randomized patients, we performed descriptive analyses without inference testing.

resultsA total of 13 participants were randomly allocated study drug (six vorapaxar and seven placebo). The median age was 56 years and seven participants (54%) were female. The median (minimum-maximum) days to functional maturation were 169 (77-287) days in the vorapaxar group and 145 (48-198) days in the placebo group. Six of the 13 (46%) participants had arteriovenous fistula functional maturation within 180 days; two of six (33%) in the vorapaxar group and four of seven (57%) in the placebo group. There was one bleeding event in the placebo group.

conclusionFewer than half of participants had functional maturation within 180 days after surgery, suggesting a major need for agents or strategies that enhance arteriovenous fistula maturation.

Indexed as

Arteriovenous Shunt, SurgicalRenal DialysisAgedCaliforniaDouble-Blind MethodEarly Termination of Clinical TrialsFemaleHemorrhageHumansKidney Failure, ChronicLactonesMaleMiddle AgedPilot ProjectsPlatelet Aggregation InhibitorsPyridinesLactonesPlatelet Aggregation InhibitorsPyridinesvorapaxarArteriovenous fistulaclinical trialdialysisthrombinVorapAccessvorapaxar

Identifiers

PMID31774037
PMCPMC8063544
OpenAlexW2990562035

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.