Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Completed

• Conditions: Venous Thromboembolism
• Interventions: Other: Non-interventional study

• Registration Number: NCT02248610
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Study Start: 2014-11
• Status Verified: 2015-08
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1343

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Non-interventional study	All participants will be treated with rivaroxaban.

Primary Outcome Measures

Name	Time	Method
Incidence of long term complications	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 Outcome Measures

Name	Time	Method
Treatment adherence	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.
Quality of life assessment	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.
Incidence of other thromboembolic events	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).
Incidence of major post-thrombotic complications	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)
Healthcare resource utilisation	Full duration of anticoagulation treatment (average of 6 months)	Healthcare resource utilisation in patients treated with long-term (\>12 months) anticoagulation
Incidence of treatment-emergent bleeding rates	5 years from diagnosis of index event (DVT or PE), annual follow-up	Long-term treatment-emergent bleeding rates (up to 5 years).
All-cause mortality	5 years from diagnosis of index event (DVT or PE), annual follow-up

Trial Locations

Locations (4)

Kings College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Basingstoke Hospital; 🇬🇧 Basingstoke, United Kingdom

Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Salisbury Hospital; 🇬🇧 Salisbury, United Kingdom