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

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism; Thromboembolism; Pulmonary Embolism; Thrombosis; Venous Thrombosis

Treatments: Drug: ASA; Drug: BAY 59-7939

Study type: Interventional

Funder types: Industry

Identifiers

NCT02064439

2013-000619-26 (EudraCT Number)

16416

Details and patient eligibility

About

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

Enrollment: 3,365 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,365 participants in 3 patient groups

Arm 1

Experimental group

Description:

Rivaroxaban 10 mg once daily for 12 months

Treatment:

Drug: BAY 59-7939

Drug: BAY 59-7939

Arm 2

Experimental group

Description:

Rivaroxaban 20 mg once daily for 12 months

Treatment:

Drug: BAY 59-7939

Drug: BAY 59-7939

Arm 3

Active Comparator group

Description:

ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months

Treatment:

Drug: ASA