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Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial.

Publication ,  Journal Article
Dember, LM; Kaufman, JS; Beck, GJ; Dixon, BS; Gassman, JJ; Greene, T; Himmelfarb, J; Hunsicker, LG; Kusek, JW; Lawson, JH; Middleton, JP ...
Published in: Clin Trials
2005

BACKGROUND: The Dialysis Access Consortium (DAC) was developed to investigate interventions to improve hemodialysis vascular access outcomes. The autogenous arteriovenous fistula created by direct connection of native artery to vein is the recommended vascular access for hemodialysis. However, it fails frequently due to clotting after surgery. PURPOSE: The DAC Early AV Fistula Thrombosis Trial tests the hypothesis that clopidogrel can prevent early fistula failure and increase the number of fistulas that ultimately become usable for hemodialysis access. This is one of two initial and concurrent trials being performed by the DAC. The companion trial investigates pharmacologic approaches to prevent venous stenosis leading to AV graft failure. METHODS: This is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll 1,284 patients over four years. Patients undergoing creation of a new native arteriovenous (AV) fistula are randomized to treatment with clopidogrel or placebo for six weeks following fistula creation surgery. The primary outcome is fistula patency at six weeks. The major secondary outcome is fistula suitability for dialysis. RESULTS: This paper examines key aspects of this study that have broad relevance to trial design including: 1) the selection of an intermediate event as the primary outcome, 2) timing of the intervention to balance efficacy and safety concerns, 3) ethical considerations arising from required modifications of concomitant drug therapy, and 4) choosing an efficacy or effectiveness evaluation of the intervention. CONCLUSIONS: This is the first, large, multicenter trial evaluating a pharmacologic approach to prevent early AV fistula failure and promote more usable fistulas for hemodialysis. The methodologic challenges identified and addressed during the development of this trial should help to inform the design of future vascular access trials, and are relevant to clinical trials addressing a wide range of questions.

Duke Scholars

Published In

Clin Trials

DOI

ISSN

1740-7745

Publication Date

2005

Volume

2

Issue

5

Start / End Page

413 / 422

Location

England

Related Subject Headings

  • Treatment Outcome
  • Ticlopidine
  • Statistics & Probability
  • Research Design
  • Renal Dialysis
  • Randomized Controlled Trials as Topic
  • Platelet Aggregation Inhibitors
  • Multicenter Studies as Topic
  • Humans
  • Graft Occlusion, Vascular
 

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Dember, L. M., Kaufman, J. S., Beck, G. J., Dixon, B. S., Gassman, J. J., Greene, T., … DAC Study Group. (2005). Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials, 2(5), 413–422. https://doi.org/10.1191/1740774505cn118oa
Dember, Laura M., James S. Kaufman, Gerald J. Beck, Bradley S. Dixon, Jennifer J. Gassman, Tom Greene, Jonathan Himmelfarb, et al. “Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial.Clin Trials 2, no. 5 (2005): 413–22. https://doi.org/10.1191/1740774505cn118oa.
Dember LM, Kaufman JS, Beck GJ, Dixon BS, Gassman JJ, Greene T, et al. Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials. 2005;2(5):413–22.
Dember, Laura M., et al. “Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial.Clin Trials, vol. 2, no. 5, 2005, pp. 413–22. Pubmed, doi:10.1191/1740774505cn118oa.
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):413–422.
Journal cover image

Published In

Clin Trials

DOI

ISSN

1740-7745

Publication Date

2005

Volume

2

Issue

5

Start / End Page

413 / 422

Location

England

Related Subject Headings

  • Treatment Outcome
  • Ticlopidine
  • Statistics & Probability
  • Research Design
  • Renal Dialysis
  • Randomized Controlled Trials as Topic
  • Platelet Aggregation Inhibitors
  • Multicenter Studies as Topic
  • Humans
  • Graft Occlusion, Vascular