Clinical trial NCT02248610: Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
Official title: Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Pulmonary embolism
PE
Deep vein thrombosis
DVT
Rivaroxaban
Venous thromboembolism
Chronic thromboembolic pulmonary hypertension
Post thrombotic limb syndrome
Root cause analysis
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-09-25
Enrollment: 1343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of long term complications
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary outcomes:
measure: Incidence of major post-thrombotic complications
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Incidence of treatment-emergent bleeding rates
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: All-cause mortality
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Treatment adherence
timeFrame: Full duration of anticoagulation treatment (average of 6 months)
measure: Quality of life assessment
timeFrame: Full duration of anticoagulation treatment (average of 6 months)
measure: Healthcare resource utilisation
timeFrame: Full duration of anticoagulation treatment (average of 6 months)
measure: Incidence of other thromboembolic events
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Other outcomes:
measure: Exploratory root-cause analysis of major bleeding and recurrent VTE events
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Analysis of the outpatient treatment of PE
timeFrame: Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits)
measure: Subgroup analysis of patients with evidence of long-term VTE-related morbidity
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
measure: Evaluation of rivaroxaban in under-studied groups
timeFrame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke Hospital
city: Bournemouth
country: United Kingdom
facility: Bournemouth Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: Salisbury
country: United Kingdom
facility: Salisbury Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: Roopen Arya, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: