Reduced-dosed rivaroxaban in the long-term prevention of VTE
Research type
Research Study
Full title
Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism The Einstein Choice Study
IRAS ID
145981
Contact name
Juliette Dehay
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2013-000619-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 4 days
Research summary
Patients with symptomatic deep-vein thrombosis (DVT) (blood clots in the leg) and/or pulmonary embolism (PE) (blood clots in the lung) who completed 6 to 12 months anticoagulant treatment for their index event will be invited to participate on this study. The purpose of this study is to investigate the best type and dose of blood thinner drugs, aspirin or rivaroxaban in treating patients with blood clots in their legs or lungs. Patients will be randomly given one of the following treatments - Rivaroxaban 20 mg; Rivaroxaban 10 mg; or aspirin enteric coated 100 mg, over a period of 12 months. The study will be double blind, which means neither the patient nor their doctor will know which treatment option the patient is on. The study is also a double dummy study, which means we are using a dummy drug which looks the same as the actual treatment to disguise the treatment the patients are actually receiving. The main objective on this study is to see which treatment, Rivaroxaban 20 mg; Rivaroxaban 10 mg; or aspirin enteric coated 100 mg, will be the best treatment to prevent recurrent blood clots.
About 2850 patients, from approximately 250 hospitals in approximately 30 countries are anticipated to participate in this study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0092
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion