SVTPhase 2/3RIVA-SVTNCT06965998
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
A Phase 2/3 study testing Full dose rivaroxaban and Low dose rivaroxaban in people with SVT and Thrombosis, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SVT, Thrombosis, Superficial Vein Thrombosis
- What is being tested?
- Full dose rivaroxaban and Low dose rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Aug 2025to Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Miriam Kimpton, MD,MSc,FRCPC contact
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Veronica Bates, BSc, CCRP, 613-737-8899 ext. 71068, vebates@ohri.ca
Tzu-Fei Wang, MD, MPH
- Not yet recruiting
Hopital Montfort
Ottawa, Ontario, K1K 0T2
Christine-Nadia Compas, 613-746-4621 ext. 3623, christinencompas@montfort.on.ca
Miriam Kimptom, MD,MSc,FRCPC
About this study
Official title: A Pilot Randomized Double-Blinded Comparison of Full Treatment Dose Rivaroxaban for 90 Days to Prophylactic Dose Rivaroxaban for 45 Days in Patients With Lower Extremity Superficial Vein Thrombosis
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:
Read more
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.
Read the detailed description
The standard or usual treatment for a superficial vein thrombosis (SVT) is to treat with a low-dose (often called a prophylactic dose) of blood thinner for 45 days. Rivaroxaban is a type of oral blood thinner that is used in the treatment and prevention of blood clots. Currently, rivaroxaban 10mg daily for 45 days is the most commonly used treatment in patients with lower extremity SVT.
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
- SVT, Thrombosis, Superficial Vein Thrombosis
- Being tested
- Full dose rivaroxaban, Low dose rivaroxaban, Placebo
- Keywords
- Pilot, Rivaroxaban, Feasibility, Full dose rivaroxaban, Treatment dose rivaroxaban, Superficial vein thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full dose rivaroxabanDrug
The intervention group will receive full dose rivaroxaban for 90 days.
Low dose rivaroxabanDrug
The comparator group will receive the standard treatment of low dose rivaroxaban.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Intervention) | Experimental | Day 1-21: 15mg Rivaroxaban twice per day Day 22-90: 20mg Rivaroxaban once a day for 69 days Receives: 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 Receives: Drug: Low dose rivaroxaban; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from when recruitment opens.
Secondary outcomes (4)
Secondary Feasibility Outcomes
The rate (%) of eligible patients that give consent to participate.
Measured: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
The rate (%) of patients that are not lost to follow-up.
Measured: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
The rate (%) of patients who complete and adhere to the study procedures.
Measured: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
Reasons why eligible patients chose not to participate.
Measured: From the start of study recruitment to the last follow-up of the last participant enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start6 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SVTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu-Fei Wang, MD,MPH, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965998
- Sponsor's protocol ID
- RIVA-SVT Pilot
- Acronym
- RIVA-SVT
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28219692Samama 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.
PubMed 20888031Blondon 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.
PubMed 21757569Wichers 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.
PubMed 15921382Duffett 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.
PubMed 30716777Frappe 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.
PubMed 24679145Leon 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.
PubMed 15570265Di 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.
PubMed 26845754Di 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.
PubMed 29478266Geersing 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.
PubMed 29678975Beyer-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.
PubMed 29222259Bauer 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.
PubMed 12070533Mathieu 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.
PubMed 38187826
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Double-Blinded Comparison of Full Treatment Dose Rivaroxaban for 90 Days to Prophylactic Dose Rivaroxaban for 45 Days in Patients With Lower Extremity Superficial Vein Thrombosis
- ClinicalTrials.gov ID
- NCT06965998
- Acronym / sponsor ID
- RIVA-SVT / RIVA-SVT Pilot
- Conditions
- SVT, Thrombosis, Superficial Vein Thrombosis
- Keywords
- Pilot, Rivaroxaban, Feasibility, Full dose rivaroxaban, Treatment dose rivaroxaban, Superficial vein thrombosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard or usual treatment for a superficial vein thrombosis (SVT) is to treat with a low-dose (often called a prophylactic dose) of blood thinner for 45 days. Rivaroxaban is a type of oral blood thinner that is used in the treatment and prevention of blood clots. Currently, rivaroxaban 10mg daily for 45 days is the most commonly used treatment in patients with lower extremity SVT.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Intervention) | Experimental | Drug: Full dose rivaroxabanDay 1-21: 15mg Rivaroxaban twice per day Day 22-90: 20mg Rivaroxaban once a day for 69 days |
| Group B (Comparator) | Active comparator | Drug: Low dose rivaroxaban, Drug: PlaceboDay 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full dose rivaroxabanThe intervention group will receive full dose rivaroxaban for 90 days. | Drug | Group A (Intervention) |
| Low dose rivaroxabanThe comparator group will receive the standard treatment of low dose rivaroxaban. | Drug | Group B (Comparator) |
| PlaceboSince 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. | Drug | Group B (Comparator) |
Primary outcome
Primary Feasibility Outcome
Time frame: 12 months from when recruitment opens.
The primary feasibility outcome of this pilot trial is the average number of patients recruited per month during the 12 month recruitment period.
4 secondary outcomes
Secondary Feasibility Outcomes
Time frame: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
Time frame: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
Time frame: From the start of study recruitment to the last follow-up of the last participant enrolled.
Secondary Feasibility Outcomes
Time frame: From the start of study recruitment to the last follow-up of the last participant enrolled.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 28219692Beyer-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: PubMed 20888031Samama 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: PubMed 21757569Blondon 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: PubMed 15921382Wichers 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.
- BackgroundDuffett 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: PubMed 30716777Duffett 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: PubMed 24679145Frappe 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: PubMed 15570265Leon 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: PubMed 26845754Di 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: PubMed 29478266Di 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: PubMed 29678975Geersing 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: PubMed 29222259Beyer-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Kimpton, MD,MSc,FRCPC contact
Tzu-Fei Wang, MD,MPH principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Full dose rivaroxaban and Low dose rivaroxaban in people with SVT and Thrombosis, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Fei Wang, MD,MPH (613-737-9988 ext. 73755, tzwang@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Outcome (time frame: 12 months from when recruitment opens.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965998, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.