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Prevention study for Venous Thromboembolism
Official title VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy
ClinicalTrials.gov ID: NCT05920343
What this study is testing
What is Rivaroxaban 10 MG?
Rivaroxaban 10 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Also referred to as Xarelto.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who are starting systemic therapy for active GU cancer (bladder, testis, ureter/renal pelvis, kidney, urethral, penile) except for prostate...
- 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.
You likely can't join if
- 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))
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.