Effectiveness Study of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— EFFECT-AF  

Official title:

Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856075
• Other study ID #: Sanofi-EFFECT-AF
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: September 7, 2015
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: La-ser Europe Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: The European Medicines Agency's (EMA)United Kingdom: Committee for Medicinal Products for Human Use (CHMP)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1015
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Praxis fuer Kardiologie, Im Muehlenbach 2B	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
La-ser Europe Limited

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Recurrence of Atrial Fibrillation	Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up	3 month; 6 month; 12-18 month	No
Secondary	Change from baseline Cardiovascular hospitalisation		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation		3 month; 6 month; 12-18 month	No
Secondary	Change from baseline Progression to permanent Atrial Fibrillation		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Congestive heart failure		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Interstitial pulmonary disease		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Liver injury/toxicity		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Renal insufficiency/failure		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Cerebrovascular accident/Stroke		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Myocardial infarction		3 month; 6 month; 12-18 month	Yes
Secondary	Change from baseline Torsade de pointes		3 month; 6 month; 12-18 month	Yes
Secondary	Death	Assessed at each follow-up: 3 month, 6 month, and 12-18 month	3 month; 6 month; 12-18 month	Yes