drugset / Trial / NCT00215774
Flecainide-Short Long Study (Flec-SL)
Completed
760 enrolled
Atrial Fibrillation Network
German Federal Ministry of Education and Research · collabGerman Research Foundation · collabMeda Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized trial to test the hypothesis that short-term pharmacological reversal of electrical remodeling after cardioversion is equally efficient to prevent recurrent atrial fibrillation as standard long-term antiarrhythmic therapy.
Timeline
- Start
- 2005-03
- Primary completion
- 2009-10
- Completion
- 2011-03
Outcome
Missed primary endpoint
paper Kaplan-Meier estimate of difference 7·9% [-1·9 to 17·7]; p=0·2081 for non-inferiority; margin prespecified at 12%). PMID 22713626 ↗
paper Short-term antiarrhythmic drug treatment after cardioversion is less effective than is long-term treatment PMID 22713626 ↗
Publications
- Background Kirchhof P, Fetsch T, Hanrath P, Meinertz T, Steinbeck G, Lehmacher W, Breithardt G. Targeted pharmacological reversal of electrical remodeling after cardioversion--rationale and design of the Flecainide Short-Long (Flec-SL) trial. Am Heart J. 2005 Nov;150(5):899. doi: 10.1016/j.ahj.2005.07.020.
- Results Kirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U, Ravens U, Samol A, Steinbeck G, Treszl A, Wegscheider K, Breithardt G. Short-term versus long-term antiarrhythmic drug treatment after cardioversion of atrial fibrillation (Flec-SL): a prospective, randomised, open-label, blinded endpoint assessment trial. Lancet. 2012 Jul 21;380(9838):238-46. doi: 10.1016/S0140-6736(12)60570-4. Epub 2012 Jun 18.
- Apostolakis S, Haeusler KG, Oeff M, Treszl A, Andresen D, Borggrefe M, Lip GY, Meinertz T, Parade U, Samol A, Steinbeck G, Wegscheider K, Breithardt G, Kirchhof P. Low stroke risk after elective cardioversion of atrial fibrillation: an analysis of the Flec-SL trial. Int J Cardiol. 2013 Oct 9;168(4):3977-81. doi: 10.1016/j.ijcard.2013.06.090. Epub 2013 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | flecainide | Small molecule | 100 mg | — |