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

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 - PALLAS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34262

Enrollment

544

Registered

2010-06-15

Start date

2010-09-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation & atrial flutter

Interventions

Dronedarone: 400 mg, one tablet twice a day with the morning and evening meals Placebo, one tablet twice a day with the morning and evening meals

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 - Patient and physician decision to allow AF to continue without further efforts to restore sinus rhythm Patients aged 65 years or older with 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 less or equal to 0.40 - Peripheral arterial occlusive disease - Aged 75 years or older with both hypertension and diabetes mellitus

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Coprimary Endpoints • Composite endpoint of first stroke, systemic arterial embolism, myocardial infarction or cardiovascular death • Composite endpoint of first unplanned cardiovascular hospitalization or death from any cause All deaths, strokes, systemic arterial embolisms and myocardial infarctions, all heart failure hospitalizations as well as all other unplanned cardiovascular hospitalizations up to the first not refuted unplanned cardiovascular hospitalization will be adjudicated by a blinded committee.	—

Measure

Time frame

Coprimary Endpoints • Composite endpoint of first stroke, systemic arterial embolism, myocardial infarction or cardiovascular death • Composite endpoint of first unplanned cardiovascular hospitalization or death from any cause All deaths, strokes, systemic arterial embolisms and myocardial infarctions, all heart failure hospitalizations as well as all other unplanned cardiovascular hospitalizations up to the first not refuted unplanned cardiovascular hospitalization will be adjudicated by a blinded committee.

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Secondary

Measure	Time frame
Secondary Endpoint • Cardiovascular death	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)