Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,343
- Locations
- 4
- Primary Endpoint
- Incidence of long term complications
Study Overview
Brief Summary
In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.
Detailed Description
United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single cohort, registry. The observation period for each patient covers the treatment period with rivaroxaban and follow up until study end. For each patient, the treating health care professional records patient demographics, medical history, signs and symptoms, diagnosis, treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data monitoring will be undertaken by the Sponsor.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban
Exclusion Criteria
- •Patients in whom follow-up is unlikely or impossible
- •Patients unable to give consent
- •Patients who receive heparin therapy for more than 48 hours
- •Patients who receive more than one dose of warfarin
- •Patients with an indication for anticoagulation other than DVT and/or PE
- •All contraindications listed in the local product information (SmPC) will form part of the exclusion criteria
Outcomes
Primary Outcomes
Incidence of long term complications
Time Frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of long term complications as composite primary end point of VTE recurrence, PTS and CTEPH in patients treated with rivaroxaban without bridging heparin therapy
Secondary Outcomes
- Treatment adherence(Full duration of anticoagulation treatment (average of 6 months))
- Quality of life assessment(Full duration of anticoagulation treatment (average of 6 months))
- Incidence of other thromboembolic events(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- Incidence of major post-thrombotic complications(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- Healthcare resource utilisation(Full duration of anticoagulation treatment (average of 6 months))
- Incidence of treatment-emergent bleeding rates(5 years from diagnosis of index event (DVT or PE), annual follow-up)
- All-cause mortality(5 years from diagnosis of index event (DVT or PE), annual follow-up)