Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Other: Non-interventional study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rivaroxaban<br>All participants will be treated with rivaroxaban. | Other: Non-interventional study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of long term complications | 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 | 5 years from diagnosis of index event (DVT or PE), annual follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major post-thrombotic complications | Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH) | 5 years from diagnosis of index event (DVT or PE), annual follow-up | 
| Incidence of treatment-emergent bleeding rates | Long-term treatment-emergent bleeding rates (up to 5 years). | 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 | 
| Treatment adherence | Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits. | Full duration of anticoagulation treatment (average of 6 months) | 
| Quality of life assessment | Regular quality of life assessment in patients diagnosed with VTE, three questionnaires to be completed at time of index event, then at second and then final clinic visits. | Full duration of anticoagulation treatment (average of 6 months) | 
| Healthcare resource utilisation | Healthcare resource utilisation in patients treated with long-term (>12 months) anticoagulation | Full duration of anticoagulation treatment (average of 6 months) | 
| Incidence of other thromboembolic events | Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke). | 5 years from diagnosis of index event (DVT or PE), annual follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism, PE, Deep vein thrombosis, DVT, Rivaroxaban, Venous thromboembolism, Chronic thromboembolic pulmonary hypertension, Post thrombotic limb syndrome, Root cause analysis