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

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

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

Key facts

Study ID

NCT00439725

Run by

Bayer

People needed

1197

Starts

2007-02-01

Expected to finish

2009-09-01

Last updated by the study team

2014-11-04

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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 [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Redlands, California, United States
• Study site — Bay Pines, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Decatur, Georgia, 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 — 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 — Pittsburgh, Pennsylvania, United States
• Study site — Corsicana, Texas, 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 — Burlington, Vermont, United States
• Study site — Fredericksburg, Virginia, United States
• Study site — Spokane, Washington, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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