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

NCT06965998 | Recruiting Phase 2 DMC

• 1 other identifier: RIVA-SVT Pilot
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

SVT; Thrombosis; Superficial Vein Thrombosis

Keywords

Pilot; Rivaroxaban; Feasibility; Full dose rivaroxaban; Treatment dose rivaroxaban; Superficial vein thrombosis

Outcome Measures

Primary Outcomes (1)

• Primary Feasibility Outcome

  The primary feasibility outcome of this pilot trial is the average number of patients recruited per month during the 12 month recruitment period.

  12 months from when recruitment opens.

Secondary Outcomes (4)

• Secondary Feasibility Outcomes

  From the start of study recruitment to the last follow-up of the last participant enrolled.

• Secondary Feasibility Outcomes

  From the start of study recruitment to the last follow-up of the last participant enrolled.

• Secondary Feasibility Outcomes

  From the start of study recruitment to the last follow-up of the last participant enrolled.

• Secondary Feasibility Outcomes

  From the start of study recruitment to the last follow-up of the last participant enrolled.

Study Arms (2)

Group A (Intervention)

EXPERIMENTAL

Day 1-21: 15mg Rivaroxaban twice per day Day 22-90: 20mg Rivaroxaban once a day for 69 days

Drug: Full dose rivaroxaban

Group B (Comparator)

ACTIVE 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

Drug: Low dose rivaroxaban; Drug: Placebo

Interventions

Full dose rivaroxaban DRUG

The intervention group will receive full dose rivaroxaban for 90 days.

Group A (Intervention)

Low dose rivaroxaban DRUG

The comparator group will receive the standard treatment of low dose rivaroxaban.

Group B (Comparator)

Placebo DRUG

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.

Group B (Comparator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age ≥ 18 years old.
• 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.
• Anticoagulation for SVT is warranted per clinicians.
• Able and willing to provide written informed consent.

You may not qualify if:

• Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
• History of PE or DVT within 6 months (180 days) of screening.
• \>5 days of any anticoagulants for the index SVT.
• Requires use of aspirin \>100mg daily or other antiplatelet agents.
• Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.).
• Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
• History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening.
• Have acute endocarditis.
• 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.
• Creatinine clearance \<30 ml/min.
• Known contraindication to treatment with rivaroxaban.
• Are participating in another interventional trial that would compromise the results or integrity of this trial as determined by the investigator.
• Pregnant or breast feeding.
• Known hereditary or acquired severe hemorrhagic disease.
• Life expectancy \<3 months.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Hopital Montfort

Ottawa, Ontario, K1K 0T2, Canada

NOT YET RECRUITING

Related Publications (14)

• 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.

  PMID: 28219692 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.

  PMID: 20888031 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.

  PMID: 21757569 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.

  PMID: 15921382 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.

  PMID: 30716777 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.

  PMID: 24679145 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.

  PMID: 15570265 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.

  PMID: 26845754 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.

  PMID: 29478266 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.

  PMID: 29678975 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.

  PMID: 29222259 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.

  PMID: 12070533 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.

  PMID: 38187826 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tzu-Fei Wang, MD,MPH

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Fei Wang, MD,MPH

CONTACT

613-737-9988; tzwang@toh.ca

Miriam Kimpton, MD,MSc,FRCPC

CONTACT

mkimpton@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 11, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)