The primary objective of this trial is to demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary Endpoint
• Cardiovascular death
Background summary
Atrial fibrillation (AF) is the most frequent sustained arrhythmia, affecting
6% of the people older than 70 years and the overall incidence rises with age.
AF is associated with a 1.5-1.9- fold increase in mortality risk and
significant morbidity causing symptom. It is common practice to restore sinus
rhythm by pharmacological means or by electrical cardioversion, after which
patients often receive antiarrhythmic treatment to reduce the change of AF
recurrence. Amiodarone (Cordarone*), an anti-arrhytmic drug with a complex
electrophysiological profile is a very effective therapy for the maintenance of
sinus rhythm post-conversion. Dronedarone is very similar to amiodarone, but
without the iodine molecule so less amiodarone related side effects can be
expected.
Given the trend for a beneficial effect of dronedarone in the AF/AFL population
derived from the data of former studies (EURIDIS/ ADONIS) on the combined
endpoint of hospitalisation for cardiovascular reasons or any death it is
expected that treatment with dronedarone can similarly decrease this combined
endpoint in high risk patients with a history of AF/AFL.
Study objective
The primary objective of this trial is to 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 and additional risk factors.
Study design
Prospective, randomized, double blind, parallel group, international,
multicenter trial evaluating the effects of dronedarone 400 mg BID
versus placebo (ratio 1:1) in patients with permanent atrial fibrillation and
additional risk factors.
Intervention
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
Study burden and risks
Patients will be followed according to schedule (page 8-9 of the protocol). A
2D electrocardiography will be done at baseline and a 12-lead ECG maximum 11
times. Besides at maximum 6 visits, bloodsamples will be taken for biochemistry
parameters. Patients may experience dronedarone related side effects.
Kampenringweg 45 D-E
2803 PE Gouda
Nederland
Kampenringweg 45 D-E
2803 PE Gouda
Nederland
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019791-73-NL |
| ClinicalTrials.gov | NCT01151137 |
| CCMO | NL32603.060.10 |