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Effectiveness Study of Atrial Fibrillation (EFFECT-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01856075
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Atrial Fibrillation

Study Design

Study Type : Observational
Actual Enrollment : 1015 participants
Observational Model: Cohort
Official Title: Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation
Study Start Date : October 2012
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients treated with dronedarone
Patients treated with dronedarone at inclusion
Patients treated with other antiarrhythmic drugs of interest

The antiarrhythmic drugs of interest to which dronedarone will be compared are:

  • Class 1a/1c antiarrhythmics
  • Sotalol
  • Amiodarone


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline Recurrence of Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
    Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up


Secondary Outcome Measures :
  1. Change from baseline Cardiovascular hospitalisation [ Time Frame: 3 month; 6 month; 12-18 month ]
  2. Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
  3. Change from baseline Progression to permanent Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
  4. Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction [ Time Frame: 3 month; 6 month; 12-18 month ]
  5. Change from baseline Congestive heart failure [ Time Frame: 3 month; 6 month; 12-18 month ]
  6. Change from baseline Interstitial pulmonary disease [ Time Frame: 3 month; 6 month; 12-18 month ]
  7. Change from baseline Liver injury/toxicity [ Time Frame: 3 month; 6 month; 12-18 month ]
  8. Change from baseline Renal insufficiency/failure [ Time Frame: 3 month; 6 month; 12-18 month ]
  9. Change from baseline Cerebrovascular accident/Stroke [ Time Frame: 3 month; 6 month; 12-18 month ]
  10. Change from baseline Myocardial infarction [ Time Frame: 3 month; 6 month; 12-18 month ]
  11. Change from baseline Torsade de pointes [ Time Frame: 3 month; 6 month; 12-18 month ]
  12. Death [ Time Frame: 3 month; 6 month; 12-18 month ]
    Assessed at each follow-up: 3 month, 6 month, and 12-18 month


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856075


Locations
Germany
Praxis fuer Kardiologie, Im Muehlenbach 2B
Bonn, Germany, 53127
Sponsors and Collaborators
La-ser Europe Limited
Investigators
Study Director: Artak Khachatryan, PhD LA-SER Europe
More Information

Responsible Party: La-ser Europe Limited
ClinicalTrials.gov Identifier: NCT01856075     History of Changes
Other Study ID Numbers: Sanofi-EFFECT-AF
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by La-ser Europe Limited:
Atrial Fibrillation
Dronedarone
Cohort
Effectiveness

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Amiodarone
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors