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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | All participants will be treated with rivaroxaban. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional study | Other |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | To assess outcomes with specific reference to the patient journey (outpatient, inpatient and primary care), with particular focus on outpatient treatment of PE. |
Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation
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| Name | Affiliation | Role |
|---|---|---|
| Roopen Arya, MBChB, PhD | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basingstoke Hospital | Basingstoke | United Kingdom | ||||
| Bournemouth Hospital |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits) |
| Subgroup analysis of patients with evidence of long-term VTE-related morbidity | To identify subgroups at higher risk of adverse events (AE) and/or long-term VTE-related morbidity (PTS and CTEPH). | 5 years from diagnosis of index event (DVT or PE), annual follow-up |
| Evaluation of rivaroxaban in under-studied groups | 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). | 5 years from diagnosis of index event (DVT or PE), annual follow-up |
| Bournemouth |
| United Kingdom |
| Kings College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Salisbury Hospital | Salisbury | United Kingdom |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D013927 | Thrombosis |