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
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 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).
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.
Inclusion Criteria:
Exclusion Criteria:
Bruxelles - Brussel, 1070, Belgium
Bruxelles - Brussel, 1200, Belgium
Ostrava-Poruba, 708 52, Czechia
Usti Nad Lebem, 401 13, Czechia
Karlsbad, Baden-Wurttemberg 76307, Germany
Vellore, Kerala 632004, India
Wellington South, 6021, New Zealand
Bruderholz, Basel-Landschaft 4101, Switzerland
Genéve 14, Genève 14 1211, Switzerland