Recruiting
Phase 2
Phase 3

Rivaroxaban

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05920343

Conditions

Venous Thromboembolism

Urologic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rivaroxaban 10 MG

Placebo control

Study Details

Brief summary:

Patients with genitourinary cancers (ex: bladder, testicular, kidney) are at high risk of developing blood clots if they receive systemic therapy (ex: chemotherapy, immunotherapy). Blood clots cause pain, may require hospitalization and invasive testing, and in some cases cause death. In fact, blood clots are one of the leading causes of death in patients with cancer. Furthermore, patients who develop a blood clot require medication to thin the blood for a prolonged (sometimes indefinite) period of time, and this can disrupt other important cancer treatments. Studies have shown that using low dose blood thinners to prevent blood clots during systemic therapy is effective in some patients with cancer. However very few patients in these studies had genitourinary cancers, therefore physicians in Canada are not sure if recommending blood thinners to patients with genitourinary cancers is useful or safe. Safety is a primary concern because blood thinners may cause bleeding, and patients with genitourinary cancers may have higher risk of bleeding than patients with other types of cancer. The investigators hypothesize that blood thinners are effective and safe for reducing blood clots in patients with genitourinary cancers. The objective of this study is to determine if a large clinical trial testing the effectiveness and safety of low dose blood thinners for preventing blood clots in patients with genitourinary cancers receiving systemic therapy is feasible.

Conditions

Venous Thromboembolism

Urologic Cancer

Study ID

NCT05920343

Start date

Nov 4, 2024

Status verified date

Jul, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate cancer.
  • Age ≥ 18
  • Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies.
  • Patients must be initiating systemic therapy with a minimum planned treatment duration of 8 weeks.

Exclusion Criteria:

  • Anticoagulation (prophylactic or therapeutic dosing) required for another indication for entire duration of study
  • Known allergies to rivaroxaban
  • Concomitant use of dual antiplatelet therapy (two antiplatelet medications oncomitantly)
  • Ongoing refractory bleeding that may be exacerbated by rivaroxaban.
  • Concomitant use of strong inducers or inhibitors of CYP3A4 or glycoprotein-P (known interaction with rivaroxaban).
  • Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault))
  • Severe liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis)
  • Thrombocytopenia < 50 x 109/L
  • Life expectancy under 6 months.
  • Pregnancy (if child bearing age under 50 and sexually active, documentation of use of effective contraception or negative B- HCG is required)
  • Patient is breastfeeding or lactating
  • History of condition at increased bleeding risk including, but not limited to:

cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the previous 4 weeks.

  • Chronic hemorrhagic disorder
  • Inability to adhere to protocol or obtain consent.
  • Patients may be excluded from the study for other reasons, at the investigator's discretion.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rivaroxaban

Participants receiving study drug (Rivaroxaban)

placebo comparator: Control

Participants receiving matched placebo

Interventions

Rivaroxaban 10 MG

The intervention in the experimental arm will be rivaroxaban, 10 mg PO once daily (prophylactic dosing) for 180 days after the start of systemic therapy or until one of the primary study outcomes occurs (VTE or major bleeding).

Placebo control

Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug

Primary outcome measure

  • Feasibility of enrollment, assesed by the number of patients accrued per month [ Time Frame: Enrollment ]

Central Contacts and Locations

Central contacts

Luke T Lavallee, MDCM MSc FRCSC

613-737-8899lulavallee@toh.ca

David J Yachnin, MSc

613-798-5555dyachnin@toh.ca

Locations

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Luke Lavallee, MDCM MSc FRCSC

613-737-8899lulavallee@toh.ca

David Yachnin, MSc

613-737-5555dyachnin@toh.ca

Principal Investigator:

Luke Lavallee, MDCM, MSc, FRCSC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Keywords

  • Genitourinary Cancer
  • Venous Thromboembolism
  • Systemic Therapy
  • Thromboprophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-10.