RecruitingPhase 3

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

Canada1,828 participantsStarted 2022-10-05

Plain-language summary

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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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

Major VTE prevention

Timeframe: 90 days (± 3 days) of randomization

Episodes of Major Bleeding

Timeframe: 90 days (± 3 days) of randomization

NCT IDNCT05029063

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Bashour Yazji