Overview
The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.
Description
TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.
Eligibility
Inclusion Criteria:
- Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
Exclusion criteria:
- CVC in place for >72 hours
- Patient requires anticoagulation for other indications
- Concomitant use of dual antiplatelet therapy
- Major bleeding event in the last 4 weeks
- Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
- Known pregnancy or plan to become pregnant in next 3 months
- Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
- Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
- Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
- Known allergy to rivaroxaban
- Life expectancy <3 months
- 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 past 4 weeks.
- Chronic hemorrhagic disorder
- Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin
only
- Refused or unable to obtain consent