Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
Phase 3
Completed
- Conditions
- Health Condition 1: null- deep-vein thrombosis or pulmonary embolism
- Registration Number
- CTRI/2007/091/000024
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria:
- Confirmed acute symptomatic proximal DVT without symptomatic PE OR Confirmed acute symptomatic PE with or without symptomatic DVT
Exclusion Criteria
Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
- Other indication for VKA than DVT and/or PE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptomatic recurrent VTE, occuring during the 3-, 6-, and 12-month study treatment periodsTimepoint: Time Frame: 3-, 6-, or 12-month study treatment period
- Secondary Outcome Measures
Name Time Method All deaths and other vascular eventsTimepoint: Time Frame: 3-, 6-, or 12-month study treatment period;Clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding)Timepoint: Time Frame: 3-, 6-, or 12-month study treatment period