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

Publication ,  Journal Article
Rogers, RK; Hiatt, WR; Patel, MR; Shishehbor, MH; White, R; Khan, ND; Bhalla, NP; Jones, WS; Low Wang, CC
Published in: Vasc Med
December 2018

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.

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Published In

Vasc Med

DOI

EISSN

1477-0377

Publication Date

December 2018

Volume

23

Issue

6

Start / End Page

513 / 522

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Ticagrelor
  • Sample Size
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Patient Selection
  • Middle Aged
  • Male
  • Lower Extremity
 

Citation

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Rogers, R. K., Hiatt, W. R., Patel, M. R., Shishehbor, M. H., White, R., Khan, N. D., … Low Wang, C. C. (2018). Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution. Vasc Med, 23(6), 513–522. https://doi.org/10.1177/1358863X18760996
Rogers, R Kevin, William R. Hiatt, Manesh R. Patel, Mehdi H. Shishehbor, Robin White, Naeem D. Khan, Narinder P. Bhalla, W Schuyler Jones, and Cecilia C. Low Wang. “Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution.Vasc Med 23, no. 6 (December 2018): 513–22. https://doi.org/10.1177/1358863X18760996.
Rogers RK, Hiatt WR, Patel MR, Shishehbor MH, White R, Khan ND, et al. Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution. Vasc Med. 2018 Dec;23(6):513–22.
Rogers, R. Kevin, et al. “Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution.Vasc Med, vol. 23, no. 6, Dec. 2018, pp. 513–22. Pubmed, doi:10.1177/1358863X18760996.
Rogers RK, Hiatt WR, Patel MR, Shishehbor MH, White R, Khan ND, Bhalla NP, Jones WS, Low Wang CC. Ticagrelor in Peripheral Artery Disease Endovascular Revascularization (TI-PAD): Challenges in clinical trial execution. Vasc Med. 2018 Dec;23(6):513–522.
Journal cover image

Published In

Vasc Med

DOI

EISSN

1477-0377

Publication Date

December 2018

Volume

23

Issue

6

Start / End Page

513 / 522

Location

England

Related Subject Headings

  • United States
  • Treatment Outcome
  • Ticagrelor
  • Sample Size
  • Platelet Aggregation Inhibitors
  • Peripheral Arterial Disease
  • Patient Selection
  • Middle Aged
  • Male
  • Lower Extremity