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NCT Number: NCT02248610

Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Basingstoke Hospital, Basingstoke, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Primary outcomes

  1. 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

  1. Incidence of major post-thrombotic complications

    Time frame: 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)

  2. Incidence of treatment-emergent bleeding rates

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

    Long-term treatment-emergent bleeding rates (up to 5 years).

  3. All-cause mortality

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

  4. Treatment adherence

    Time frame: 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.

  5. Quality of life assessment

    Time frame: 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.

  6. Healthcare resource utilisation

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

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

  7. Incidence of other thromboembolic events

    Time frame: 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).

Other outcomes

  1. Exploratory root-cause analysis of major bleeding and recurrent VTE events

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

  2. Analysis of the outpatient treatment of PE

    Time frame: 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.

  3. Subgroup analysis of patients with evidence of long-term VTE-related morbidity

    Time frame: 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).

  4. Evaluation of rivaroxaban in under-studied groups

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • Bayer

Registry information

Acronym: FIRST

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2014
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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