Follow-up in Rivaroxaban Patients in Setting of Thromboembolism (FIRST)

King's College Hospital NHS Trust

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Other: Non-interventional study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02248610

FIRST registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,343 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,343 participants in 1 patient group

Rivaroxaban

Description:

All participants will be treated with rivaroxaban.

Treatment:

Other: Non-interventional study