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Gibson CM, Mack MJ, Lee VT, et al. Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose. Am Heart J. 2021;245:19-28doi: 10.1016/j.ahj.2021.10.188.
Gibson, C. M., Mack, M. J., Lee, V. T., Schneider, D. J., Sellke, F. W., Ohman, E. M., Thourani, V. H., Doros, G., Kroger, H., Cutlip, D. E., & Deliargyris, E. N. (2021). Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose. American heart journal, 24519-28. https://doi.org/10.1016/j.ahj.2021.10.188
Gibson, C Michael, et al. "Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose." American heart journal vol. 245 (2021): 19-28. doi: https://doi.org/10.1016/j.ahj.2021.10.188
Gibson CM, Mack MJ, Lee VT, Schneider DJ, Sellke FW, Ohman EM, Thourani VH, Doros G, Kroger H, Cutlip DE, Deliargyris EN. Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose. Am Heart J. 2021 Nov 01;245:19-28. doi: 10.1016/j.ahj.2021.10.188. Epub 2021 Nov 01. PMID: 34736855.
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Am Heart J. 2021 Nov 01;245:19-28. doi: 10.1016/j.ahj.2021.10.188. Epub 2021 Nov 01.

Rationale and design of the safe and timely antithrombotic removal - ticagrelor (STAR-T) trial: A prospective, multi-center, double-blind, randomized controlled trial evaluating reductions in postoperative bleeding with intraoperative removal of ticagrelor by the drugsorb™-ATR device in patients undergoing cardiothoracic surgery within 48 hours from last ticagrelor dose.

American heart journal

C Michael Gibson, Michael J Mack, Victoria T Lee, David J Schneider, Frank W Sellke, E Magnus Ohman, Vinod H Thourani, Gheorghe Doros, Hans Kroger, Donald E Cutlip, Efthymios N Deliargyris

Affiliations

  1. The Baim Institute and Harvard Medical School, Boston, MA. Electronic address: [email protected].
  2. Baylor Scott & White Health, Baylor Scott & White Research Institute, Dallas, TX.
  3. CytoSorbents Inc, Princeton, NJ.
  4. Department of Medicine and Cardiovascular Research Institute, University of Vermont, Burlington, VT.
  5. Division of Cardiothoracic Surgery, Alpert Medical School of Brown University, Providence, RI.
  6. Duke Clinical Research Institute, Duke Program for Advanced Coronary Disease, Duke University Medical Center, Durham, NC.
  7. Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA.
  8. The Baim Institute and Harvard Medical School, Boston, MA; Boston University School of Public Health, Boston, MA.
  9. The Baim Institute and Harvard Medical School, Boston, MA.

PMID: 34736855 DOI: 10.1016/j.ahj.2021.10.188

Abstract

BACKGROUND: Ticagrelor is often administered to patients with acute coronary syndromes. However, when these patients require urgent or emergent cardiothoracic (CT) surgery the presence of ticagrelor significantly increases surgical bleeding. The goal of the current trial is to evaluate the effectiveness and safety of the DrugSorb-ATR hemoadsorption device for the intraoperative removal of ticagrelor to reduce postoperative bleeding in the above patient population. The Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) Trial is a multi-center, double-blind, randomized, controlled trial enrolling patients who require cardiothoracic surgery on cardiopulmonary bypass (CPB) within 48 hours of last ticagrelor dose.

METHODS: Subjects will be randomized 1:1 to receive either the DrugSorb-ATR device or an identical sham device during CPB. The study will enroll up to 120 subjects at 20 U.S centers, and the primary outcome is the composite of fatal perioperative bleeding, moderate/severe/massive bleeding according to the Universal Definition of Perioperative Bleeding in Cardiac Surgery (UDPB), and 24 hours chest tube drainage. The components of the composite are hierarchically ranked according to clinical significance and the primary analysis will utilize the Win Ratio method. Percent change in ticagrelor levels before and after CPB (drug removal) will be the key secondary endpoint. An independent Clinical Events Committee will adjudicate all clinical endpoints including safety endpoints relating to postoperative thrombotic events. Subjects will be followed through 30 days after the index operation.

CONCLUSIONS: The results from STAR-T, if positive, will potentially support FDA market approval for DrugSorb-ATR, and provide a solution to an important unmet clinical need.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

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