AnticoagulationRE-FITNCT02921126
Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in Italy.
Trial summary
To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- How many people
- 9,914 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2017to 2 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria.
Who may be able to join
- are at least 18 years of age at index date
- Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
- Had at least 1 claim with diagnosis of AF anytime in their records
Who cannot join
- Have a record that is indicative of Valvular Atrial Fibrillation during this period
- Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
- Have more than one OAC exposure which starts on the same date
Trial locations and contacts
1 site in 1 country.
About this study
To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.
- Conditions
- Anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Group | Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day | |
| Low Dose Group | Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day | |
| Other Dose Group | Invalid Doses / Off-Label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy
Measured: Approximately 30 months
Secondary outcomes (5)
Distribution of patient demographics at the time of OAC initiation
Measured: at baseline
Distribution of clinical characteristics at the time of OAC initiation
Measured: at baseline
Composite of number and percentage of patients who are persistent with their newly prescribed OAC
Measured: Approximately 30 months
Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy
Measured: Approximately 30 months
Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC
Measured: Approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start30 Apr 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Retrospective
- Enrolment
- 9,914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921126
- Sponsor's protocol ID
- CV185-494
- Acronym
- RE-FIT
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
- ClinicalTrials.gov ID
- NCT02921126
- Acronym / sponsor ID
- RE-FIT / CV185-494
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,914 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 3 Oct 2016 (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.
To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Group | – | –Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day |
| Low Dose Group | – | –Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day |
| Other Dose Group | – | –Invalid Doses / Off-Label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- are at least 18 years of age at index date
- Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
- Had at least 1 claim with diagnosis of AF anytime in their records
Key exclusion criteria (3 listed)
- Have a record that is indicative of Valvular Atrial Fibrillation during this period
- Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
- Have more than one OAC exposure which starts on the same date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy
Time frame: Approximately 30 months
5 secondary outcomes
Distribution of patient demographics at the time of OAC initiation
Time frame: at baseline
Distribution of clinical characteristics at the time of OAC initiation
Time frame: at baseline
Composite of number and percentage of patients who are persistent with their newly prescribed OAC
Time frame: Approximately 30 months
Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy
Time frame: Approximately 30 months
Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC
Time frame: Approximately 30 months
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 8 Aug 2018.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in Italy.
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 3 inclusion and 3 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy (time frame: Approximately 30 months). 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 8 Aug 2018.