Venous Thromboembolism
Conditions
Keywords
Pulmonary embolism, PE, Deep vein thrombosis, DVT, Rivaroxaban, Venous thromboembolism, Chronic thromboembolic pulmonary hypertension, Post thrombotic limb syndrome, Root cause analysis
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.
Interventions
OTHERNon-interventional study
Sponsors
Bayer
King's College Hospital NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of long term complications | 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 5 years from diagnosis of index event (DVT or PE), annual follow-up | — |
| Treatment adherence | Full duration of anticoagulation treatment (average of 6 months) | Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits. |
| Quality of life assessment | Full duration of anticoagulation treatment (average of 6 months) | 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. |
| Healthcare resource utilisation | Full duration of anticoagulation treatment (average of 6 months) | Healthcare resource utilisation in patients treated with long-term (\>12 months) anticoagulation |
| Incidence of other thromboembolic events | 5 years from diagnosis of index event (DVT or PE), annual follow-up | Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke). |
| Incidence of major post-thrombotic complications | 5 years from diagnosis of index event (DVT or PE), annual follow-up | Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH) |
| Incidence of treatment-emergent bleeding rates | 5 years from diagnosis of index event (DVT or PE), annual follow-up | Long-term treatment-emergent bleeding rates (up to 5 years). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis of patients with evidence of long-term VTE-related morbidity | 5 years from diagnosis of index event (DVT or PE), annual follow-up | To identify subgroups at higher risk of adverse events (AE) and/or long-term VTE-related morbidity (PTS and CTEPH). |
| Evaluation of rivaroxaban in under-studied groups | 5 years from diagnosis of index event (DVT or PE), annual follow-up | To evaluate risks of rivaroxaban in patient populations for which safety information is limited or missing (eg pregnancy, breastfeeding, patients with significant organ impairment, extremes of age). |
| Exploratory root-cause analysis of major bleeding and recurrent VTE events | 5 years from diagnosis of index event (DVT or PE), annual follow-up | — |
| Analysis of the outpatient treatment of PE | Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits) | To assess outcomes with specific reference to the patient journey (outpatient, inpatient and primary care), with particular focus on outpatient treatment of PE. |
Countries
United Kingdom
Outcome results
None listed