A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
NCT ID: NCT06965998
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2025-08-06
2027-02-28
Brief Summary
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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.
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Detailed Description
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Recent studies of participants with SVT suggest that treatment with full-dose (sometimes called therapeutic dose) blood thinners could be promising in preventing additional complications from SVT such as:
* A new blood clot in the deep veins of the legs or arms
* A new pulmonary embolism (a blood clot in the lungs)
* A recurrence or extension of the existing SVT (the existing clot comes back after treatment is stopped or gets bigger)
The Investigators are studying whether a full-dose of rivaroxaban for 90 days could prevent or improve additional complications from SVT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A (Intervention)
Day 1-21: 15mg Rivaroxaban twice per day Day 22-90: 20mg Rivaroxaban once a day for 69 days
Full dose rivaroxaban
The intervention group will receive full dose rivaroxaban for 90 days.
Group B (Comparator)
Day 1-21: 10mg Rivaroxaban once a day AND placebo once a day Day 22-45: 10mg Rivaroxaban once a day Day 46-90: Placebo once a day for 45 days
Low dose rivaroxaban
The comparator group will receive the standard treatment of low dose rivaroxaban.
Placebo
Since the treatment arm has an AM and PM dose of study drug from Day 1-21, the comparator group will take 1 placebo pill in the PM to keep the two arms blinded.
Interventions
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Full dose rivaroxaban
The intervention group will receive full dose rivaroxaban for 90 days.
Low dose rivaroxaban
The comparator group will receive the standard treatment of low dose rivaroxaban.
Placebo
Since the treatment arm has an AM and PM dose of study drug from Day 1-21, the comparator group will take 1 placebo pill in the PM to keep the two arms blinded.
Eligibility Criteria
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Inclusion Criteria
2. Objectively confirmed diagnosis within 14 days of an acute symptomatic SVT of the lower extremities by standardized CUS, where SVT is defined as incompressibility of a venous segment located along the course of a known superficial vein.
3. Anticoagulation for SVT is warranted per clinicians.
4. Able and willing to provide written informed consent.
Exclusion Criteria
2. History of PE or DVT within 6 months (180 days) of screening.
3. \>5 days of any anticoagulants for the index SVT.
4. Requires use of aspirin \>100mg daily or other antiplatelet agents.
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.).
6. Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
7. History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening.
8. Have acute endocarditis.
9. Thrombocytopenia (platelet count \<50,000/uL), acute hepatitis, chronic active hepatitis, cirrhosis with severe hepatic impairment defined by a Childs-Pugh class B or C.
10. Creatinine clearance \<30 ml/min.
11. Known contraindication to treatment with rivaroxaban.
12. Are participating in another interventional trial that would compromise the results or integrity of this trial as determined by the investigator.
13. Pregnant or breast feeding.
14. Known hereditary or acquired severe hemorrhagic disease.
15. Life expectancy \<3 months.
16. Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Tzu-Fei Wang, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Hopital Montfort
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RIVA-SVT Pilot
Identifier Type: -
Identifier Source: org_study_id
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