Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

Phase 3

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: Placebo (for Dronedarone)
Drug: Dronedarone

Registration Number: NCT01151137

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors

Secondary Objective:

* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Detailed Description: The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 3236

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo (for Dronedarone)	Placebo (for Dronedarone) twice a day until the CSED
Dronedarone	Dronedarone	Dronedarone 400 mg twice a day until the CSED

Primary Outcome Measures

Name	Time	Method
Overview of the Two Co-primary Outcomes	From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)	First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions \[MI\], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks \[TIA\], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.
Time to First Co-primary Outcome (Cumulative Incidence Function)	From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)	Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.
Time to Second Co-primary Outcome (Cumulative Incidence Function)	From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)	Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.

Secondary Outcome Measures

Name	Time	Method
Deaths	From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)	Deaths were classified according to the primary cause of death.
Time to Cardiovascular Death (Cumulative Incidence Function)	From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)	Time to cardiovascular death was defined as the time from randomization to the death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.