Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism

Treatments: Drug: Enoxaparin overlapping with and followed by VKA; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439777

11702b

2006-004495-13 (EudraCT Number)

Details and patient eligibility

About

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 pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Full description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Enrollment: 4,833 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed acute symptomatic proximal PE with or without symptomatic DVT

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,833 participants in 2 patient groups

Rivaroxaban (Xarelto, BAY59-7939)

Experimental group

Description:

Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Enoxaparin/VKA

Active Comparator group

Description:

Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)

Treatment:

Drug: Enoxaparin overlapping with and followed by VKA