Clinical trial NCT05279833: Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
Official title: SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 87810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \[over 12 months\])

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria for potential participants are:

* Children/adolescents
* Permanent atrial fibrillation (AFib)

Primary outcomes:
measure: Number of participants with Cardiovascular (CV) hospitalization
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with ventricular proarrhythmia
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of all-cause mortality events
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of cardiovascular mortality events
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with atrial fibrillation (AFib) recurrence
timeFrame: As reported in studies included in the systematic review up to 10 years
Secondary outcomes:
measure: Number of participants with myocardial infarction
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with stroke
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with heart failure hospitalization
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with AFib hospitalization
timeFrame: As reported in studies included in the systematic review up to 10 years
measure: Number of participants with conduction disorders
timeFrame: As reported in studies included in the systematic review up to 10 years
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Sanofi-Aventis, France
Study officials:
affiliation: Sanofi
name: Clinical Sciences and Operations
role: STUDY_DIRECTOR
References:
citation: 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.