Oral Direct Factor Xa Inhibitor Rivaroxaban In Patients With Acute Symptomatic Pulmonary Embolism With Or Without Symptomatic Dee-Vein Thrombosis: Einstein-PE Evaluation - Full Text View

Purpose

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 PE with or without symptomatic DVT (Einstein-PE).

Condition	Intervention	Phase
Pulmonary Embolism	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin followed by VKE	Phase III

MedlinePlus related topics:

Pulmonary Embolism

ChemIDplus related topics:

Enoxaparin Sodium Antithrombin III Rivaroxaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

Further study details as provided by Bayer:

Primary Outcome Measures:

Symptomatic recurrent VTE, occuring during the 3-, 6-, and 12-month study treatment periods [ Time Frame: 3-, 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding) [ Time Frame: 3-, 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]
All deaths and other vascular events [ Time Frame: 3-, 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	3300
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroaxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Arm 2: Active Comparator	Drug: Enoxaparin followed by VKE Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKE should be started as soon as possible but not later than 48 hours after randomization.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed acute symptomatic 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439777

Contacts


Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com

Contact: For trial location information (Phone Menu Options '3' or '4')	(+) 1-888-84 22937

Show 384 Study Locations

Sponsors and Collaborators

Bayer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	11702b, EudraCT 2006-004495-13, 11702a
First Received:	February 23, 2007
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00439777
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vascular Diseases

Venous Thrombosis

Antithrombin III

Thrombosis

Enoxaparin

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Bayer Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00439777