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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2007/091/000026

Enrollment

1300

Registered

2008-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Venous Thromboembolism

Interventions

Intervention1: Rivaroxaban (BAY59-7939): Patients randomized to rivaroxaban will receive rivaraoxaban 20 mg once-daily. Route of administration: oral (tablet) Duration of treatment: 6 or 12 months (de

Eligibility

Inclusion criteria

Inclusion 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

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PETimepoint: Time Frame: 6-, or 12-month study treatment period	—

Secondary

Measure	Time frame
All death and other vascular eventsTimepoint: Time Frame: 6-, or 12-month study treatment period;Clinically relevant bleedingTimepoint: Time Frame: 6-, or 12-month study treatment period;Time-to-first major bleedingTimepoint: Time Frame: 6-, or 12-month study treatment period	—

Countries

India

Contacts

Public ContactDr Ashish Gawde

Country Medical Director India

ashish.gawde@bayer.com02225311201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026