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
- Conditions
- Health Condition 1: null- Venous Thromboembolism
- Registration Number
- CTRI/2007/091/000026
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1300
Inclusion Criteria:
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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