Atrial Fibrillation Clinical Trial
— PRESERVE-SROfficial title:
A Single Site, Interventional, Comparative Study to Evaluate the Safety and Efficacy of Ranolazine Plus Metoprolol Combination vs. FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences
Verified date | December 2018 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Atrial fibrillation (AF) is the most common arrhythmia in clinical practice with a prevalence reaching 5% in patients older than 65 years and an incidence that increases progressively with age.1 According to the most recent guidelines, class Ic anti-arrhythmic drugs are considered the first line treatment in patients without significant structural heart disease. Flecainide is effective in preventing AF recurrences in 31-61% of cases according to different studies.2-5 A recent study showed that the combination of Flecainide and Metoprolol improves effective rhythm control in patients with persistent symptomatic AF compared to Flecainide or Metoprolol alone.6 In contrast, the combination of Flecainide and Metoprolol conferred no significant benefit over Flecainide alone in patients with paroxysmal AF. This suggests different underlying mechanisms for paroxysmal and persistent AF. Pulmonary veins are likely the main focus triggering paroxysmal AF while in persistent AF the role of pulmonary veins is less important.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - patients with AF - recently converted to sinus rhythm (>24hrs and < 7 days) - admitted in the 3rd University Cardiology Clinic of Ippokrateion Hospital - eligible to participate in the study and follow the study procedures - signed informed consent Exclusion Criteria: - use of IC antiarrhythmic agents or - Sotalol during the last 48 hours, - chronic use of oral or intravenous Amiodarone for the last 48 hours, - recent acute coronary syndrome, - heart failure New York Heart Association class III or IV, - severe left ventricular dysfunction with left ventricular ejection fraction <40%, - atrioventricular conduction disorders (atrioventricular block, - complete left bundle branch block and bi-fascicular block), - heart rate < 50 bpm, - sick sinus syndrome, - thyroid dysfunction and severe pulmonary, renal, or - liver disease - - not eligible to participate in the study and follow the study procedures - no signed informed consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Elpen Pharmaceutical Co. Inc. |
Aliot E, Capucci A, Crijns HJ, Goette A, Tamargo J. Twenty-five years in the making: flecainide is safe and effective for the management of atrial fibrillation. Europace. 2011 Feb;13(2):161-73. doi: 10.1093/europace/euq382. Epub 2010 Dec 7. Review. — View Citation
Anderson JL, Gilbert EM, Alpert BL, Henthorn RW, Waldo AL, Bhandari AK, Hawkinson RW, Pritchett EL. Prevention of symptomatic recurrences of paroxysmal atrial fibrillation in patients initially tolerating antiarrhythmic therapy. A multicenter, double-blind, crossover study of flecainide and placebo with transtelephonic monitoring. Flecainide Supraventricular Tachycardia Study Group. Circulation. 1989 Dec;80(6):1557-70. — View Citation
Burashnikov A, Di Diego JM, Zygmunt AC, Belardinelli L, Antzelevitch C. Atrium-selective sodium channel block as a strategy for suppression of atrial fibrillation: differences in sodium channel inactivation between atria and ventricles and the role of ranolazine. Circulation. 2007 Sep 25;116(13):1449-57. Epub 2007 Sep 4. — View Citation
Burashnikov A, Sicouri S, Di Diego JM, Belardinelli L, Antzelevitch C. Synergistic effect of the combination of ranolazine and dronedarone to suppress atrial fibrillation. J Am Coll Cardiol. 2010 Oct 5;56(15):1216-24. doi: 10.1016/j.jacc.2010.08.600. — View Citation
Capucci A, Piangerelli L, Ricciotti J, Gabrielli D, Guerra F. Flecainide-metoprolol combination reduces atrial fibrillation clinical recurrences and improves tolerability at 1-year follow-up in persistent symptomatic atrial fibrillation. Europace. 2016 Nov;18(11):1698-1704. Epub 2016 Feb 17. — View Citation
De Ferrari GM, Maier LS, Mont L, Schwartz PJ, Simonis G, Leschke M, Gronda E, Boriani G, Darius H, Guillamón Torán L, Savelieva I, Dusi V, Marchionni N, Quintana Rendón M, Schumacher K, Tonini G, Melani L, Giannelli S, Alberto Maggi C, Camm AJ; RAFFAELLO Investigators (see Online Supplementary Appendix for List of Participating Centers and Investigators). Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study. Heart Rhythm. 2015 May;12(5):872-8. doi: 10.1016/j.hrthm.2015.01.021. Epub 2015 Jan 17. — View Citation
Fragakis N, Koskinas KC, Katritsis DG, Pagourelias ED, Zografos T, Geleris P. Comparison of effectiveness of ranolazine plus amiodarone versus amiodarone alone for conversion of recent-onset atrial fibrillation. Am J Cardiol. 2012 Sep 1;110(5):673-7. doi: 10.1016/j.amjcard.2012.04.044. Epub 2012 May 22. — View Citation
Fragakis N, Koskinas KC, Vassilikos V. Ranolazine as a promising treatment option for atrial fibrillation: electrophysiologic mechanisms, experimental evidence, and clinical implications. Pacing Clin Electrophysiol. 2014 Oct;37(10):1412-20. doi: 10.1111/pace.12486. Epub 2014 Aug 19. Review. — View Citation
Kirstein M, Eickhorn R, Langenfeld H, Kochsiek K, Antoni H. Influence of beta-adrenergic stimulation on the fast sodium current in the intact rat papillary muscle. Basic Res Cardiol. 1991 Sep-Oct;86(5):441-8. — View Citation
Koskinas KC, Fragakis N, Katritsis D, Skeberis V, Vassilikos V. Ranolazine enhances the efficacy of amiodarone for conversion of recent-onset atrial fibrillation. Europace. 2014 Jul;16(7):973-9. doi: 10.1093/europace/eut407. Epub 2014 Jan 27. — View Citation
Murdock DK, Reiffel JA, Kaliebe J, Larrain G. The Conversion of Paroxysmal or Initial Onset Atrial Fibrillation with Oral Ranolazine: Implications for a New
Naccarelli GV, Dorian P, Hohnloser SH, Coumel P. Prospective comparison of flecainide versus quinidine for the treatment of paroxysmal atrial fibrillation/flutter. The Flecainide Multicenter Atrial Fibrillation Study Group. Am J Cardiol. 1996 Jan 25;77(3):53A-59A. — View Citation
Schubert B, Vandongen AM, Kirsch GE, Brown AM. Inhibition of cardiac Na+ currents by isoproterenol. Am J Physiol. 1990 Apr;258(4 Pt 2):H977-82. — View Citation
Sicouri S, Burashnikov A, Belardinelli L, Antzelevitch C. Synergistic electrophysiologic and antiarrhythmic effects of the combination of ranolazine and chronic amiodarone in canine atria. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):88-95. doi: 10.1161/CIRCEP.109.886275. Epub 2009 Dec 1. — View Citation
Sicouri S, Glass A, Belardinelli L, Antzelevitch C. Antiarrhythmic effects of ranolazine in canine pulmonary vein sleeve preparations. Heart Rhythm. 2008 Jul;5(7):1019-26. doi: 10.1016/j.hrthm.2008.03.018. Epub 2008 Mar 21. — View Citation
Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. — View Citation
van Wijk LM, den Heijer P, Crijns HJ, van Gilst WH, Lie KI. Flecainide versus quinidine in the prevention of paroxysms of atrial fibrillation. J Cardiovasc Pharmacol. 1989 Jan;13(1):32-6. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of 1-year-recurrences | efficacy and safety of the combination of RN and Metoprolol vs. the combination of Flecainide and Metoprolol in preventing AF recurrences during a 1-year follow-up period in patients with AF of longer than 24-hour duration who were cardioverted to sinus rhythm either pharmacologically or electrically | 12 months | |
Secondary | Number of 48-hours-recurrences | Time to the first documented AF recurrence excluding patients with recurrences in the first 48 hours | 48 hours |
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