39039039STM4001: Rivaroxaban in Cancer Patients with high risk of VTE
Research type
Research Study
Full title
Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
IRAS ID
190810
Contact name
David Propper
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2015-001630-21
Duration of Study in the UK
1 years, 1 months, 25 days
Research summary
Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer. VTE is a blood clot that occurs inside a blood vessel. Rivaroxaban has already been shown to be effective in preventing VTE in patients undergoing hip/knee replacement surgery as well as reducing VTE recurrence in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE - a blood clot in the lung).
The purpose of this study is to see if the study drug rivaroxaban is useful for treating patients at risk of developing blood clots while undergoing cancer treatment when compared to placebo. Placebo looks just like rivaroxaban and is given the same way but has no active drug in it.
This study will enrol men and women, 18 years of age and older, with various cancer types, an expected survival of more than 6 months and the intention of continuing systemic cancer therapy during the study treatment period as a component of their standard of care cancer treatment.
A target of approximately 700 participants worldwide will be randomly assigned into the study in a 1:1 ratio to 1 of 2 treatment groups (rivaroxaban or placebo) with approximately 350 participants per treatment group.
The study consists of 3 periods: a 2-week screening period, a 180-day double-blind treatment period (where neither the doctor or patient know the treatment assignment) with an end-of-treatment (EOT) visit, and a 30-day post-treatment follow-up period with a Day 210/end-of-study (EOS) visit. The duration of participation in the study for each subject is approximately 32 weeks.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1812
Date of REC Opinion
15 Dec 2015
REC opinion
Further Information Favourable Opinion