| Designs & Populations | Study design | Multi-centre, randomized, open-label, parallel-group, active controlled, event-driven non-inferiority study; central independent adjudication committee for suspected clinical outcomes was blinded to treatment allocation |
| Locations | Approximately 300 centres worldwide in more than 30 countries including US, Canada, Australia, and countries from western and eastern Europe, Asia, and Africa |
| Randomized (N) | 3,449 patients | 4,832 patients |
| Inclusion criteria | Confirmed proximal DVT without symptomatic PE | Confirmed acute symptomatic PE with or without symptomatic DVT |
| Exclusion criteria |
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic drug to treat the current thrombotic episode Treatment with therapeutic dosages of heparin, LMWH, or fondaparinux for more than 48 hours pre-randomization, or more than a single dose of VKA pre-randomization Creatinine clearance < 30 mL/min Active bleeding or high risk of bleeding, contraindicating treatment with enoxaparin or VKA, as well as any other contraindication listed in the local labelling of warfarin, acenocoumarol, or enoxaparin
|
| Drugs | Intervention | Rivaroxaban 15 mg b.i.d. for 3 weeks, followed by 20 mg q.d. P.O. |
| Comparator(s) | Enoxaparin 1 mg/kg b.i.d. SC VKA (acenocoumarol or warfarin) INR 2.0–3.0 P.O. |
| Duration | Phase: |
|---|
| Active treatment | 3, 6, or 12 months |
| Follow-up | 30 days |
| Outcomes | Primary end point | Recurrent VTE, i.e., the composite of recurrent DVT or non-fatal or fatal PE |
| Other end points |
Composite of the primary efficacy outcome and all deaths Health care resources utilization Net clinical benefit as composite of the primary efficacy outcome and major bleeding events Individual components of the primary and secondary efficacy outcome
|
| Notes | Publications | The EINSTEIN Investigators 2010,5 Buller et al. 2008,28 and the Clinical Study Report4 | Buller et al. 2012,6 Van Es et al. 201329 and the Clinical Study Report7 |
