Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05279833
• Collaborator: (none)
• Enrollment: 87,810
• Location: 1
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 14216.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: dronedarone; Drug: sotalol

Study Design

• Study Type: Observational
• Actual Enrollment: 87810 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
• Actual Study Start Date: Sep 24, 2021
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Outcome Measures

Primary Outcome Measures

1. 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

2. Number of participants with ventricular proarrhythmia [As reported in studies included in the systematic review up to 10 years]

3. Number of all-cause mortality events [As reported in studies included in the systematic review up to 10 years]

4. Number of cardiovascular mortality events [As reported in studies included in the systematic review up to 10 years]

   includes arrhythmia-related mortality

5. Number of participants with atrial fibrillation (AFib) recurrence [As reported in studies included in the systematic review up to 10 years]

Secondary Outcome Measures

1. Number of participants with myocardial infarction [As reported in studies included in the systematic review up to 10 years]

2. Number of participants with stroke [As reported in studies included in the systematic review up to 10 years]

3. Number of participants with heart failure hospitalization [As reported in studies included in the systematic review up to 10 years]

4. Number of participants with AFib hospitalization [As reported in studies included in the systematic review up to 10 years]

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis, France	Chilly-Mazarin		France	91380

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences and Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT05279833
• Other Study ID Numbers: CSA0010
• First Posted: Mar 15, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Sotalol; Dronedarone

Study Results

No Results Posted as of Apr 21, 2022