Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Venous Thromboembolism Clinical Trial

— FIRST  

Official title:

Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248610
• Other study ID #: FIRST registry
• Status: Completed
• Start date: November 2014
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2015
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1343
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Non-interventional study

Locations

Country	Name	City	State
United Kingdom	Basingstoke Hospital	Basingstoke
United Kingdom	Bournemouth Hospital	Bournemouth
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	Salisbury Hospital	Salisbury

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Bayer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory root-cause analysis of major bleeding and recurrent VTE events		5 years from diagnosis of index event (DVT or PE), annual follow-up
Other	Analysis of the outpatient treatment of PE	To assess outcomes with specific reference to the patient journey (outpatient, inpatient and primary care), with particular focus on outpatient treatment of PE.	Full duration of outpatient care (every clinic visit), until discharge (average of 6 months, 3 patient visits)
Other	Subgroup analysis of patients with evidence of long-term VTE-related morbidity	To identify subgroups at higher risk of adverse events (AE) and/or long-term VTE-related morbidity (PTS and CTEPH).	5 years from diagnosis of index event (DVT or PE), annual follow-up
Other	Evaluation of rivaroxaban in under-studied groups	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).	5 years from diagnosis of index event (DVT or PE), annual follow-up
Primary	Incidence of long term complications	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	5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary	Incidence of major post-thrombotic complications	Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH)	5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary	Incidence of treatment-emergent bleeding rates	Long-term treatment-emergent bleeding rates (up to 5 years).	5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary	All-cause mortality		5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary	Treatment adherence	Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits.	Full duration of anticoagulation treatment (average of 6 months)
Secondary	Quality of life assessment	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.	Full duration of anticoagulation treatment (average of 6 months)
Secondary	Healthcare resource utilisation	Healthcare resource utilisation in patients treated with long-term (>12 months) anticoagulation	Full duration of anticoagulation treatment (average of 6 months)
Secondary	Incidence of other thromboembolic events	Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke).	5 years from diagnosis of index event (DVT or PE), annual follow-up