Phase 3 N=3,449 Randomized Treatment

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

Venous Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT00440193 ↗

Enrolled (actual)

3,449

Serious AEs

13.8%

Results posted

Jan 2013

Primary outcome: Primary: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment — 2.1; 3.0 Percentage of participants — p=< 0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rivaroxaban (Xarelto, BAY59-7939) (Drug); Enoxaparin followed by VKA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment	2.1; 3.0	< 0.0001 sig
SECONDARY Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment	4.0; 5.1	0.044 sig
SECONDARY Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment	2.9; 4.2	0.027 sig
SECONDARY Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment	0.9; 1.6	—
SECONDARY Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)	8.1; 8.1	0.77
SECONDARY Percentage of Participants With All Deaths	2.4; 3.0; 1.0; 1.1; 1.2; 1.5	—
SECONDARY Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)	0.7; 0.8	—

Summary

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Eligibility Criteria

Inclusion Criteria

Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria

Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
Other indication for VKA than DVT and/or PE
The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00440193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.