NCT05279833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87,810

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

February 17, 2022

Last Update Submit

January 5, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

  • Number of participants with Cardiovascular (CV) hospitalization

    CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke

    As reported in studies included in the systematic review up to 10 years

  • Number of participants with ventricular proarrhythmia

    As reported in studies included in the systematic review up to 10 years

  • Number of all-cause mortality events

    As reported in studies included in the systematic review up to 10 years

  • Number of cardiovascular mortality events

    includes arrhythmia-related mortality

    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 Outcomes (5)

  • 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 AFib 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

Interventions

dronedaroneDRUG

Pharmaceutical form is tablet and route of administration is oral

Also known as: Multaq®
sotalolDRUG

Pharmaceutical form is tablet and route of administration is oral

Also known as: BETAPACE®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib \[over 12 months\])

You may qualify if:

  • 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

You may not qualify if:

  • Children/adolescents
  • Permanent atrial fibrillation (AFib)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis, France

Chilly-Mazarin, 91380, France

Location

Related Publications (1)

  • 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.

    PMID: 37025083RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

DronedaroneSotalol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmiodaroneBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Clinical Sciences and Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 15, 2022

Study Start

September 24, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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

Locations

FR(1)