Clinical trial NCT01856075: Effectiveness Study of Atrial Fibrillation
Official title: Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Dronedarone
Cohort
Effectiveness
Lead sponsor: La-ser Europe Limited
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an international observational multicentre study to be conducted in the following four countries: Germany, Spain, Italy and USA. Patients will be will be recruited from cardiology clinics, both hospital and non-hospital based, depending on particulars of treatment pathway of ppAF patients in each country.

Brief summary: This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.


Eligibility criteria: Inclusion Criteria:

* Patient 18 years old or above
* Patient with paroxysmal or persistent atrial fibrillation
* Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
* Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
* Patient with at least 6 months of medical and treatment information prior to the start of the index drug
* Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy).

Exclusion Criteria:

* Patient with heart failure (NYHA class IV)
* Patient with permanent Atrial Fibrillation
* Patient with psychiatric conditions preventing the participation to the study according to the physician

Primary outcomes:
measure: Change from baseline Recurrence of Atrial Fibrillation
timeFrame: 3 month; 6 month; 12-18 month
Secondary outcomes:
measure: Change from baseline Cardiovascular hospitalisation
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Progression to permanent Atrial Fibrillation
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Congestive heart failure
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Interstitial pulmonary disease
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Liver injury/toxicity
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Renal insufficiency/failure
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Cerebrovascular accident/Stroke
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Myocardial infarction
timeFrame: 3 month; 6 month; 12-18 month
measure: Change from baseline Torsade de pointes
timeFrame: 3 month; 6 month; 12-18 month
measure: Death
timeFrame: 3 month; 6 month; 12-18 month
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Praxis fuer Kardiologie, Im Muehlenbach 2B
Study officials:
affiliation: LA-SER Europe
name: Artak Khachatryan, PhD
role: STUDY_DIRECTOR
References: