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โ† Trials
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VTE Prevention With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllOttawa Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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 use

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Rivaroxaban 10 MG
  • Placebo control
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Where

1 site
Ottawa Hospital Research Institute
Ottawa, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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