Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

King's College Hospital NHS Trust1,343 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,343

Conditions

Venous Thromboembolism

Interventions

Non-interventional studyOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (4)

Basingstoke Hospital

Basingstoke, United Kingdom

Bournemouth Hospital

Bournemouth, United Kingdom

Kings College Hospital NHS Foundation Trust

London, United Kingdom

Salisbury Hospital

Salisbury, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up

Secondary Outcomes

Incidence of major post-thrombotic complications

Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH)

Time frame: 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).

Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up

All-cause mortality

Time frame: 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.

Time frame: 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.

Time frame: Full duration of anticoagulation treatment (average of 6 months)

Healthcare resource utilisation

Healthcare resource utilisation in patients treated with long-term (\>12 months) anticoagulation

Data from ClinicalTrials.gov

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