Conditions: Venous Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1197
Healthy volunteers: no

Brief 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).

Detailed 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.

Arms:
arm 1: Participants were to receive rivaroxaban 20 mg oral tablet once daily arm 2: Participants were to receive matching placebo oral tablet once daily

Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Placebo
Intervention descriptions: intervention 1: Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily. intervention 2: Patients allocated to placebo will receive a matching placebo tablet once daily.

Protocol document: