NCT02475837

Brief Summary

The Objectives of this study are:

  1. 1.To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo.
  2. 2.To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo.
  3. 3.To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 26, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

June 12, 2015

Results QC Date

December 4, 2018

Last Update Submit

January 11, 2019

Conditions

AV Fistula

Outcome Measures

Primary Outcomes (1)

  • Time to AV Fistula Functional Maturation

    Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).

    up to 238 days

Secondary Outcomes (3)

  • Count of Participants With AV Fistula Use

    up to 238 days

  • Count Participants With AV Fistula Patency

    150-238 days

  • Count of All Participants With Bleeding Events

    up to 238 days

Study Arms (2)

Vorapaxar intervention

ACTIVE COMPARATOR

This arm will receive the study drug: Vorapaxar sulfate. 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).

Drug: Vorapaxar sulfate

Placebo intervention

PLACEBO COMPARATOR

This arm will receive the matching placebo. 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).

Drug: Placebo

Interventions

Vorapaxar sulfateDRUG

The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery.

Also known as: Zontivity
Vorapaxar intervention
PlaceboDRUG

The placebo will match the study drug, vorapaxar sulfate, in appearance. A 12-week supply will be dispensed to enrolled patients on the first day following surgery.

Placebo intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • Receiving or planning to receive maintenance hemodialysis
  • Ability to sign informed consent
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Univeristy

Stanford, California, 94305, United States

Location

Related Publications (11)

  • Brescia MJ, Cimino JE, Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med. 1966 Nov 17;275(20):1089-92. doi: 10.1056/NEJM196611172752002. No abstract available.

    PMID: 5923023BACKGROUND

  • Andrassy K, Malluche H, Bornefeld H, Comberg M, Ritz E, Jesdinsky H, Mohring K. Prevention of p.o. clotting of av. cimino fistulae with acetylsalicyl acid. Results of a prospective double blind study. Klin Wochenschr. 1974 Apr 1;52(7):348-9. doi: 10.1007/BF01468835. No abstract available.

    PMID: 4600820BACKGROUND

  • Crowther MA, Clase CM, Margetts PJ, Julian J, Lambert K, Sneath D, Nagai R, Wilson S, Ingram AJ. Low-intensity warfarin is ineffective for the prevention of PTFE graft failure in patients on hemodialysis: a randomized controlled trial. J Am Soc Nephrol. 2002 Sep;13(9):2331-7. doi: 10.1097/01.asn.0000027356.16598.99.

    PMID: 12191977BACKGROUND

  • Fiskerstrand CE, Thompson IW, Burnet ME, Williams P, Anderton JL. Double-blind randomized trial of the effect of ticlopidine in arteriovenous fistulas for hemodialysis. Artif Organs. 1985 Feb;9(1):61-3. doi: 10.1111/j.1525-1594.1985.tb04349.x.

    PMID: 3888153BACKGROUND

  • Osborn G, Escofet X, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002786. doi: 10.1002/14651858.CD002786.pub2.

    PMID: 18843633BACKGROUND

  • Kaufman JS. Antithrombotic agents and the prevention of access thrombosis. Semin Dial. 2000 Jan-Feb;13(1):40-6. doi: 10.1046/j.1525-139x.2000.00012.x. No abstract available.

    PMID: 10740671BACKGROUND

  • Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, Himmelfarb J, Hunsicker LG, Kusek JW, Lawson JH, Middleton JP, Radeva M, Schwab SJ, Whiting JF, Feldman HI; DAC Study Group. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413-22. doi: 10.1191/1740774505cn118oa.

    PMID: 16317810BACKGROUND

  • Hirano K. The roles of proteinase-activated receptors in the vascular physiology and pathophysiology. Arterioscler Thromb Vasc Biol. 2007 Jan;27(1):27-36. doi: 10.1161/01.ATV.0000251995.73307.2d. Epub 2006 Nov 9.

    PMID: 17095716BACKGROUND

  • Morrow DA, Braunwald E, Bonaca MP, Ameriso SF, Dalby AJ, Fish MP, Fox KA, Lipka LJ, Liu X, Nicolau JC, Ophuis AJ, Paolasso E, Scirica BM, Spinar J, Theroux P, Wiviott SD, Strony J, Murphy SA; TRA 2P-TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med. 2012 Apr 12;366(15):1404-13. doi: 10.1056/NEJMoa1200933. Epub 2012 Mar 24.

    PMID: 22443427BACKGROUND

  • Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20-33. doi: 10.1056/NEJMoa1109719. Epub 2011 Nov 13.

    PMID: 22077816BACKGROUND

  • Kosoglou T, Kraft WK, Kumar B, Statkevich P, Xuan F, Ma L, Jennings LK, Schiller JE, Langdon RB, Cutler DL. Pharmacokinetics and pharmacodynamics of the novel PAR-1 antagonist vorapaxar in patients with end-stage renal disease. Eur J Clin Pharmacol. 2012 Jul;68(7):1049-56. doi: 10.1007/s00228-012-1217-6. Epub 2012 Feb 8.

    PMID: 22315147BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

vorapaxar

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

The study did not reach its planned enrollment.

Results Point of Contact

Title
Ken Mahaffey MD
Organization
Stanford University
kmahaf@stanford.edu
650.723.3096

Study Officials

  • Matthew W Mell, MD, MS

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Kenneth W Mahaffey, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co Investigator

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 19, 2015

Study Start

August 26, 2015

Primary Completion

October 23, 2017

Study Completion

October 23, 2017

Last Updated

January 14, 2019

Results First Posted

January 14, 2019

Record last verified: 2019-01

Locations

US(1)