Venous ThromboembolismFIRSTNCT02248610
Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
An observational study of Venous Thromboembolism, run by King's College Hospital NHS Trust at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Non-interventional study
- How many people
- 1,343 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Nov 2014to 31 Jul 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Basingstoke Hospital
Basingstoke
Bournemouth Hospital
Bournemouth
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Salisbury Hospital
Salisbury
About this study
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Non-interventional study
- Keywords
- Pulmonary embolism, PE, Deep vein thrombosis, DVT, Rivaroxaban, Venous thromboembolism, Chronic thromboembolic pulmonary hypertension, Post thrombotic limb syndrome, Root cause analysis
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | All participants will be treated with rivaroxaban. Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Secondary outcomes (7)
Incidence of major post-thrombotic complications
Incidence (up to 5 years) of individual major sequelae (VTE recurrence, PTS and CTEPH)
Measured: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of treatment-emergent bleeding rates
Long-term treatment-emergent bleeding rates (up to 5 years).
Measured: 5 years from diagnosis of index event (DVT or PE), annual follow-up
All-cause mortality
Measured: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Treatment adherence
Adherence will be measured by patient interviews with a validated questionnaire conducted during follow-up visits.
Measured: Full duration of anticoagulation treatment (average of 6 months)
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.
Measured: Full duration of anticoagulation treatment (average of 6 months)
Healthcare resource utilisation
Healthcare resource utilisation in patients treated with long-term (>12 months) anticoagulation
Measured: Full duration of anticoagulation treatment (average of 6 months)
Incidence of other thromboembolic events
Long-term incidence rates of other thromboembolic events (e.g. myocardial infarction and ischaemic stroke).
Measured: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2014
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,343 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Roopen Arya, MBChB, PhD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248610
- Sponsor's protocol ID
- FIRST registry
- Acronym
- FIRST
- Status last verified
- Aug 2015
- First submitted
- 8 Sep 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
- ClinicalTrials.gov ID
- NCT02248610
- Acronym / sponsor ID
- FIRST / FIRST registry
- Conditions
- Venous Thromboembolism
- Keywords
- Pulmonary embolism, PE, Deep vein thrombosis, DVT, Rivaroxaban, Venous thromboembolism, Chronic thromboembolic pulmonary hypertension, Post thrombotic limb syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,343 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2014 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Other: Non-interventional studyAll participants will be treated with rivaroxaban. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have not recieved bridging anticoagulation
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional study | Other | Rivaroxaban |
Primary outcome
Incidence of long term complications
Time frame: 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
7 secondary outcomes
Incidence of major post-thrombotic complications
Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Incidence of treatment-emergent bleeding rates
Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
All-cause mortality
Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Treatment adherence
Time frame: Full duration of anticoagulation treatment (average of 6 months)
Quality of life assessment
Time frame: Full duration of anticoagulation treatment (average of 6 months)
Healthcare resource utilisation
Time frame: Full duration of anticoagulation treatment (average of 6 months)
Incidence of other thromboembolic events
Time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roopen Arya, MBChB, PhD principal investigator
King's College Hospital NHS Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by King's College Hospital NHS Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of long term complications (time frame: 5 years from diagnosis of index event (DVT or PE), annual follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.