A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg

Summary

The goal of this clinical trial, called a pilot study or a feasibility study, is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. This type of study includes a small number of participants so it is not expected to prove how safe the treatment is or how well the treatment works. The main question it hopes to answer is: 1.What is the average number of patients that are recruited per month during the 12 month study period? To test the study plan, adults being treated for a superficial vein thrombosis (SVT), which is a blood clot in the superficial veins of the leg, will be given a type of blood thinner called rivaroxaban. Half of the participants in this study will be given the standard (low-dose) rivaroxaban for 45 days, then 45 days of placebo (a substance that looks like the study medication but does not have any active or medicinal ingredients). The other half of participants will be given full-dose rivaroxaban for a total of 90 days. The placebo in this study is not intended to have any effect on the participants blood clot. A placebo is used to make the results of the study more reliable.

Timeline

Start

2025-08-06

Primary completion

2026-08

Completion

2027-02

Publications

• Background Beyer-Westendorf J, Schellong SM, Gerlach H, Rabe E, Weitz JI, Jersemann K, Sahin K, Bauersachs R; SURPRISE investigators. Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial. Lancet Haematol. 2017 Mar;4(3):e105-e113. doi: 10.1016/S2352-3026(17)30014-5. Epub 2017 Feb 16.
• Background Samama MM. The mechanism of action of rivaroxaban--an oral, direct Factor Xa inhibitor--compared with other anticoagulants. Thromb Res. 2011 Jun;127(6):497-504. doi: 10.1016/j.thromres.2010.09.008. Epub 2010 Oct 2.
• Background Blondon M, Righini M, Bounameaux H, Veenstra DL. Fondaparinux for isolated superficial vein thrombosis of the legs: a cost-effectiveness analysis. Chest. 2012 Feb;141(2):321-329. doi: 10.1378/chest.11-0625. Epub 2011 Jul 14.
• Background Wichers IM, Di Nisio M, Buller HR, Middeldorp S. Treatment of superficial vein thrombosis to prevent deep vein thrombosis and pulmonary embolism: a systematic review. Haematologica. 2005 May;90(5):672-7.
• Background Duffett L. Management of Superficial Venous Thrombosis: A Systematic Review of Literature and Survey of Canadian Physicians. Thesis. Université d'Ottawa / University of Ottawa; 2018. doi:10.20381/ruor-21377
• Background Duffett L, Kearon C, Rodger M, Carrier M. Treatment of Superficial Vein Thrombosis: A Systematic Review and Meta-Analysis. Thromb Haemost. 2019 Mar;119(3):479-489. doi: 10.1055/s-0039-1677793. Epub 2019 Feb 4.
• Background Frappe P, Buchmuller-Cordier A, Bertoletti L, Bonithon-Kopp C, Couzan S, Lafond P, Leizorovicz A, Merah A, Presles E, Preynat P, Tardy B, Decousus H; STEPH Study Group. Annual diagnosis rate of superficial vein thrombosis of the lower limbs: the STEPH community-based study. J Thromb Haemost. 2014 Jun;12(6):831-8. doi: 10.1111/jth.12575.
• Background Leon L, Giannoukas AD, Dodd D, Chan P, Labropoulos N. Clinical significance of superficial vein thrombosis. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):10-7. doi: 10.1016/j.ejvs.2004.09.021.
• Background Di Minno MN, Ambrosino P, Ambrosini F, Tremoli E, Di Minno G, Dentali F. Prevalence of deep vein thrombosis and pulmonary embolism in patients with superficial vein thrombosis: a systematic review and meta-analysis. J Thromb Haemost. 2016 May;14(5):964-72. doi: 10.1111/jth.13279. Epub 2016 Mar 15.
• Background Di Nisio M, Wichers IM, Middeldorp S. Treatment for superficial thrombophlebitis of the leg. Cochrane Database Syst Rev. 2018 Feb 25;2(2):CD004982. doi: 10.1002/14651858.CD004982.pub6.
• Background Geersing GJ, Cazemier S, Rutten F, Fitzmaurice DA, Hoes AW. Incidence of superficial venous thrombosis in primary care and risk of subsequent venous thromboembolic sequelae: a retrospective cohort study performed with routine healthcare data from the Netherlands. BMJ Open. 2018 Apr 20;8(4):e019967. doi: 10.1136/bmjopen-2017-019967.
• Background Beyer-Westendorf J. Controversies in venous thromboembolism: to treat or not to treat superficial vein thrombosis. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):223-230. doi: 10.1182/asheducation-2017.1.223.
• Background Bauer KA, Hawkins DW, Peters PC, Petitou M, Herbert JM, van Boeckel CA, Meuleman DG. Fondaparinux, a synthetic pentasaccharide: the first in a new class of antithrombotic agents - the selective factor Xa inhibitors. Cardiovasc Drug Rev. 2002 Winter;20(1):37-52. doi: 10.1111/j.1527-3466.2002.tb00081.x.
• Background Mathieu ME, Duffett L, Caiano L, Scarvelis D, Code C, Wells P, Le Gal G. Management and outcomes of superficial vein thrombosis: a single-center retrospective study. Res Pract Thromb Haemost. 2023 Nov 18;8(1):102263. doi: 10.1016/j.rpth.2023.102263. eCollection 2024 Jan.

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