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

Last updated: October 28, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Cardiovascular Disease

Deep Vein Thrombosis

Treatment

N/A

Clinical Study ID

NCT00439725
11899
2006-004494-96
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 breastfeeding. Proper contraceptive measures are defined as a method of contraception with afailure rate < 1 % during the course of the study (including the observationalperiod). These methods of contraception according to the note for guidance onnon-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference onHarmonization]/286/95, modification) include consistent and correct use of hormonecontaining implants and injectables, combined oral contraceptives, hormone containingintrauterine devices, surgical sterilization, sexual abstinence and vasectomy

Study Design

Total Participants: 1197
Study Start date:
February 01, 2007
Estimated Completion Date:
September 30, 2009

Study Description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

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