Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution.

Published

Journal Article

There is limited evidence to guide clinical decision-making for antiplatelet therapy in peripheral artery disease (PAD) in the setting of lower extremity endovascular treatment. The Ticagrelor in Peripheral Artery Disease Endovascular Revascularization Study (TI-PAD) evaluated the role of ticagrelor versus aspirin as monotherapy in the management of patients following lower extremity endovascular revascularization. The trial failed to recruit the targeted number of patients, likely due to aspects of the design including the lack of option for dual antiplatelet therapy, and inability to identify suitable patients at study sites. In response, the protocol underwent amendments, but these changes did not adequately stimulate recruitment, and thus TI-PAD was prematurely terminated. This article describes the rationale for TI-PAD and challenges in trial design, subject recruitment and trial operations to better inform the conduct of future trials in PAD revascularization. ClinicalTrials.gov Identifier: NCT02227368.

Full Text

Duke Authors

Cited Authors

  • Rogers, RK; Hiatt, WR; Patel, MR; Shishehbor, MH; White, R; Khan, ND; Bhalla, NP; Jones, WS; Low Wang, CC

Published Date

  • April 2018

Published In

Start / End Page

  • 1358863X18760996 -

PubMed ID

  • 29629845

Pubmed Central ID

  • 29629845

Electronic International Standard Serial Number (EISSN)

  • 1477-0377

International Standard Serial Number (ISSN)

  • 1358-863X

Digital Object Identifier (DOI)

  • 10.1177/1358863x18760996

Language

  • eng