Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT05279833
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87810
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of cardiovascular mortality events As reported in studies included in the systematic review up to 10 years includes arrhythmia-related mortality
Number of all-cause mortality events As reported in studies included in the systematic review up to 10 years Number of participants with Cardiovascular (CV) hospitalization 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 As reported in studies included in the systematic review up to 10 years Number of participants with atrial fibrillation (AFib) recurrence As reported in studies included in the systematic review up to 10 years
- Secondary Outcome Measures
Name Time Method Number of participants with AFib hospitalization As reported in studies included in the systematic review up to 10 years Number of participants with myocardial infarction As reported in studies included in the systematic review up to 10 years Number of participants with stroke As reported in studies included in the systematic review up to 10 years Number of participants with heart failure hospitalization As reported in studies included in the systematic review up to 10 years Number of participants with conduction disorders As reported in studies included in the systematic review up to 10 years Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants
Trial Locations
- Locations (1)
Sanofi-Aventis, France
🇫🇷Chilly-Mazarin, France