Actively Recruiting
VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy
Led by Ottawa Hospital Research Institute · Updated on 2025-07-10
120
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients starting systemic therapy for active genitourinary cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except prostate cancer
- Age 18 years or older
- Eligible systemic therapies include chemotherapy, targeted therapies (tyrosine kinase inhibitors and antiangiogenic therapy), and immunotherapies
- Planned systemic therapy duration of at least 8 weeks
You will not qualify if you...
- Need for anticoagulation for another reason during the entire study period
- Known allergy to rivaroxaban
- Use of dual antiplatelet therapy
- Ongoing bleeding that may worsen with rivaroxaban
- Use of strong CYP3A4 or glycoprotein-P inducers or inhibitors
- Severe kidney problems (creatinine clearance less than 30 mL/min)
- Severe liver disease such as acute or chronic hepatitis or cirrhosis
- Low platelet count under 50 x 10^9/L
- Life expectancy less than 6 months
- Pregnancy without effective contraception or negative pregnancy test if of childbearing age
- Breastfeeding or lactating
- History of bleeding disorders or recent bleeding events including cerebral infarction or active peptic ulcer disease
- Chronic hemorrhagic disorder
- Inability to follow the study protocol or provide consent
- Other exclusions at investigator discretion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
L
Luke T Lavallee, MDCM MSc FRCSC
CONTACT
D
David J Yachnin, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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