Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Dronedarone Drug: Placebo (for Dronedarone) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessing the Clinical Benefit of Dronedarone 400mg BID on Top of Standard Therapy in Patients With Permanent Atrial Fibrillation and Additional Risk Factors |
- Overview of the Two Co-primary Outcomes [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
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) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
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) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
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.
- Deaths [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]Deaths were classified according to the primary cause of death.
- Time to Cardiovascular Death (Cumulative Incidence Function) [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
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.
- Overview of Cardiovascular Events [ Time Frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year) ] [ Designated as safety issue: No ]
- Overview of Adverse Events [AE] [ Time Frame: from first study drug intake up to 10 days after the last study drug intake ] [ Designated as safety issue: Yes ]AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
| Enrollment: | 3236 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dronedarone
Dronedarone 400 mg twice a day until the CSED
|
Drug: Dronedarone
Film-coated tablet Oral administration under fed conditions (during breakfast and dinner) Other Names:
|
|
Placebo Comparator: placebo
Placebo (for Dronedarone) twice a day until the CSED
|
Drug: Placebo (for Dronedarone)
film-coated tablet strictly identical in appearance Oral administration under fed conditions (during breakfast and dinner) |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Permanent AF defined by the presence of all of the following criteria:
- Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter;
- Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization;
- No evidence of sinus rhythm in the period between these two documentations of AF;
- Decision of the patient and physician to allow AF to continue without further efforts to restore sinus rhythm.
At least one of the following risk criteria:
- Coronary artery disease;
- Prior stroke or Transient Ischemic Attack [TIA];
- Symptomatic heart failure;
- Left ventricular ejection fraction [LVEF] less or equal to 0.40;
- Peripheral arterial occlusive disease;
- Aged 75 years or older with both hypertension and diabetes mellitus.
Exclusion criteria:
- Paroxysmal AF;
- Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm;
- Heart failure of New-York Heart Association [NYHA] class IV or recent unstable NYHA class III.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Show 37 Study Locations| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01151137 History of Changes |
| Other Study ID Numbers: | EFC11405, 2010-019791-73, U1111-1116-5566 |
| Study First Received: | June 22, 2010 |
| Results First Received: | September 14, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013