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

This study is currently recruiting participants.

Verified by Bayer, January 2009

Sponsors and Collaborators:	Bayer Johnson & Johnson Pharmaceutical Research & Development, L.L.C. - within the U.S., Johnson&Johnson is sponsor
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00439777

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: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: 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:	February 2010
Estimated Primary Completion Date:	February 2010 (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 339 Study Locations

Sponsors and Collaborators

Bayer

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

- within the U.S., Johnson&Johnson is sponsor

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
Study First Received:	February 23, 2007
Last Updated:	January 12, 2009
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 January 16, 2009