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

Completed · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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).

Key facts

Study ID

NCT00439777

Run by

Bayer

People needed

4833

Starts

2007-03-01

Expected to finish

2011-12-01

Last updated by the study team

2014-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed acute symptomatic proximal PE with or without symptomatic DVT

You may not qualify if…

• 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.

Where it is running

• Study site — Redlands, California, United States
• Study site — Bay Pines, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Covington, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Camp Hill, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — San Antonio, Texas, United States
• Study site — Murray, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Fredericksburg, Virginia, United States
• Study site — Spokane, Washington, United States
• Study site — Tacoma, Washington, United States
• Study site — Les Escaldes, Andorra
• Study site — Garran, Australian Capital Territory, Australia
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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