Atrial FibrillationNCT05279833
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Sanofi at 1 site in France.
Trial summary
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- dronedarone and sotalol
- Type of treatment
- Pill or oral medicine
- How many people
- 87,810 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2021to 31 Mar 2022
- 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: Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months])
Who may be able to join
- Following eligibility criteria are defined to select relevant studies from the literature
- Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
- Participants have received either Dronedarone or Sotalol
- controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies
Who cannot join
- Children/adolescents
- Permanent atrial fibrillation (AFib)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.
- Conditions
- Atrial Fibrillation
- Being tested
- dronedarone, sotalol
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dronedaroneDrug
Also called Multaq®
Pharmaceutical form is tablet and route of administration is oral
sotalolDrug
Also called BETAPACE®
Pharmaceutical form is tablet and route of administration is oral
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Cardiovascular (CV) hospitalization
CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with ventricular proarrhythmia
Measured: As reported in studies included in the systematic review up to 10 years
Number of all-cause mortality events
Measured: As reported in studies included in the systematic review up to 10 years
Number of cardiovascular mortality events
includes arrhythmia-related mortality
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with atrial fibrillation (AFib) recurrence
Measured: As reported in studies included in the systematic review up to 10 years
Secondary outcomes (5)
Number of participants with myocardial infarction
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with stroke
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with heart failure hospitalization
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with AFib hospitalization
Measured: As reported in studies included in the systematic review up to 10 years
Number of participants with conduction disorders
Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants
Measured: As reported in studies included in the systematic review up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start24 Sep 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 87,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences and Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279833
- Sponsor's protocol ID
- CSA0010
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Singh JP, Blomstrom-Lundqvist C, Turakhia MP, Camm AJ, Fazeli MS, Kreidieh B, Crotty C, Kowey PR. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023 Jun;46(6):589-597. doi: 10.1002/clc.24011. Epub 2023 Apr 6.
PubMed 37025083
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
- ClinicalTrials.gov ID
- NCT05279833
- Acronym / sponsor ID
- CSA0010
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87,810 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- 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.
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months])
Key inclusion criteria (4 listed)
- Following eligibility criteria are defined to select relevant studies from the literature
- Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
- Participants have received either Dronedarone or Sotalol
- controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies
Key exclusion criteria (2 listed)
- Children/adolescents
- Permanent atrial fibrillation (AFib)
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 |
|---|---|---|
| dronedaroneAlso: Multaq®Pharmaceutical form is tablet and route of administration is oral | Drug | – |
| sotalolAlso: BETAPACE®Pharmaceutical form is tablet and route of administration is oral | Drug | – |
Primary outcome
Number of participants with Cardiovascular (CV) hospitalization
Time frame: As reported in studies included in the systematic review up to 10 years
CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke
Number of participants with ventricular proarrhythmia
Time frame: As reported in studies included in the systematic review up to 10 years
Number of all-cause mortality events
Time frame: As reported in studies included in the systematic review up to 10 years
Number of cardiovascular mortality events
Time frame: As reported in studies included in the systematic review up to 10 years
includes arrhythmia-related mortality
Number of participants with atrial fibrillation (AFib) recurrence
Time frame: As reported in studies included in the systematic review up to 10 years
5 secondary outcomes
Number of participants with myocardial infarction
Time frame: As reported in studies included in the systematic review up to 10 years
Number of participants with stroke
Time frame: As reported in studies included in the systematic review up to 10 years
Number of participants with heart failure hospitalization
Time frame: As reported in studies included in the systematic review up to 10 years
Number of participants with AFib hospitalization
Time frame: As reported in studies included in the systematic review up to 10 years
Number of participants with conduction disorders
Time frame: As reported in studies included in the systematic review up to 10 years
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 9 Jan 2024.
- Results publication: PubMed 37025083Singh JP, Blomstrom-Lundqvist C, Turakhia MP, Camm AJ, Fazeli MS, Kreidieh B, Crotty C, Kowey PR. Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clin Cardiol. 2023 Jun;46(6):589-597. doi: 10.1002/clc.24011. Epub 2023 Apr 6.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Atrial Fibrillation (AF)
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.
Clinical Sciences and Operations study director
Sanofi
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 Atrial Fibrillation, run by Sanofi at 1 site in France.
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 4 inclusion and 2 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 9 Jan 2024. 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 France. 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?
Number of participants with Cardiovascular (CV) hospitalization (time frame: As reported in studies included in the systematic review up to 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279833, which also lists 1 linked publication.
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 9 Jan 2024.