Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-07-31

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.

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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.

Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

All participants will be treated with rivaroxaban.

Non-interventional study

Intervention Type OTHER

Interventions

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Non-interventional study

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No