VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT05920343
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Urologic Cancer
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rivaroxaban 10 MG — DRUG
    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 — OTHER
    Identical to Rivaroxaban intervention except participants will receive a matched placebo instead of the study drug

Study Details

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.

Key Dates

First listed
Jun 27, 2023
Start date
Nov 4, 2024
Status verified
Jul 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Rivaroxaban
    Participants receiving study drug (Rivaroxaban)
  • Placebo Comparator: Control
    Participants receiving matched placebo

Primary Outcome Measure

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

Central Contacts

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