CompletedPhase 3

Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

United States3,365 participantsStarted 2014-03-05

Plain-language summary

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week Exclusion Criteria: * Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min

What they're measuring

Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism

Timeframe: Up to 12 months, at least 6 months

Number of Participants With First Treatment-emergent Major Bleeding

Timeframe: Up to 12 months, at least 6 months

Trial details

NCT IDNCT02064439

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-22

Results submitted2017-09-12

View on ClinicalTrials.gov More Pulmonary Embolism trials