Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease

Summary

The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs. The main questions it aims to answer are: * Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure? * Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment? Researchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better. Participants will: * Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure * Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure * Have medications adjusted based on blood test results if assigned to the TARGET group

Timeline

Start

2025-04-29

Primary completion

2027-04-29

Completion

2027-06-30

Publications

• Background Lee I, Suarez S, Hall R, Majumdar M, Bellomo T, Jessula S, Nuzzolo K, Jefferson DM, Zacharias N, Dua A. Optimizing platelet inhibition in peripheral artery disease: A comparison of mono-antiplatelet therapy and dual-antiplatelet therapy using thromboelastography. Vascular. 2025 Feb;33(1):3-18. doi: 10.1177/17085381241237005. Epub 2024 Mar 5.
• Background Bates KJ, Moore MM, Cibotti-Sun M. 2024 Lower Extremity Peripheral Artery Disease Guideline-at-a-Glance. J Am Coll Cardiol. 2024 Jun 18;83(24):2605-2609. doi: 10.1016/j.jacc.2024.04.003. Epub 2024 May 14. No abstract available.
• Background Suarez S, Agrawal A, Patel S, Grobman B, Ghandour S, Morena L, Rodriguez A, Machlus K, Roy T, Eagleton M, Dua A. The Impact of Sex on Antiplatelet and Anticoagulant Thromboprophylaxis in Patients With Peripheral Artery Disease Post-revascularization. Ann Surg. 2024 Sep 1;280(3):463-472. doi: 10.1097/SLA.0000000000006375. Epub 2024 Jun 11.
• Background Suarez Ferreira S, Agrawal A, Lee I, Rodriguez A, Cieri I, Young E, Patel S, Ghandour S, Morena L, Hagos F, Grobman B, Machlus K, Roy T, Dua A. The Use of Clot Strength as a Predictor of Thrombosis in Peripheral Artery Disease. Ann Vasc Surg. 2024 Dec;109:273-283. doi: 10.1016/j.avsg.2024.06.041. Epub 2024 Jul 26.
• Background Majumdar M, Hall RP, Feldman Z, Goudot G, Sumetsky N, Jessula S, Kirshkaln A, Bellomo T, Chang D, Cardenas J, Patell R, Eagleton M, Dua A. Predicting Arterial Thrombotic Events Following Peripheral Revascularization Using Objective Viscoelastic Data. J Am Heart Assoc. 2023 Jan 3;12(1):e027790. doi: 10.1161/JAHA.122.027790. Epub 2022 Dec 24.
• Background Majumdar M, Waller D, Poyant J, McElroy I, Lella S, Feldman ZM, Levine E, Kim Y, Nuzzolo K, Kirshkaln A, DeCarlo C, Dua A. Variability of antiplatelet response in patients with peripheral artery disease. J Vasc Surg. 2023 Jan;77(1):208-215.e3. doi: 10.1016/j.jvs.2022.08.015. Epub 2022 Aug 24.
• Background Hess CN, Norgren L, Ansel GM, Capell WH, Fletcher JP, Fowkes FGR, Gottsater A, Hitos K, Jaff MR, Nordanstig J, Hiatt WR. A Structured Review of Antithrombotic Therapy in Peripheral Artery Disease With a Focus on Revascularization: A TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative. Circulation. 2017 Jun 20;135(25):2534-2555. doi: 10.1161/CIRCULATIONAHA.117.024469.
• Background Owens CD, Ho KJ, Conte MS. Lower extremity vein graft failure: a translational approach. Vasc Med. 2008 Feb;13(1):63-74. doi: 10.1177/1358863X07083432.
• Background Aronow WS. Peripheral arterial disease in the elderly. Clin Interv Aging. 2007;2(4):645-54. doi: 10.2147/cia.s2412.

Drugs

Indications