Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

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:	NCT00439725

Purpose

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study).

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Rivaroxaban (BAY59-7939) Drug: Placebo	Phase III

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Antithrombin III Rivaroxaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Once-Daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

Further study details as provided by Bayer:

Primary Outcome Measures:

Symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE [ Time Frame: 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time-to-first major bleeding [ Time Frame: 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]
Clinically relevant bleeding [ Time Frame: 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]
All death and other vascular events [ Time Frame: 6-, or 12-month study treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	1300
Study Start Date:	February 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) Patients randomized to rivaroxaban will receive rivaraoxaban 20 mg once-daily.
Arm 2: Placebo Comparator	Drug: Placebo Patients allocated to placebo will receive a matching placebo tablet once daily.

Eligibility

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

Criteria

Inclusion Criteria:

- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

Legal lower age limitations (country specific)
Indication for VKA other than DVT and/or PE
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439725

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 321 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:	11899, EudraCT No: 2006-004494-96
Study First Received:	February 23, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00439725
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
Venous Thromboembolism
Antithrombin III
Recurrence
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009