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Yuricheva Yu.A.

Chazov National Medical Research Centre of Cardiology

Belyaeva M.M.

Chazov National Medical Research Centre of Cardiology

Dzaurova K.M.

Chazov National Medical Research Centre of Cardiology

Krymukova M.A.

Chazov National Medical Research Centre of Cardiology

Sokolov S.F.

Chazov National Medical Research Centre of Cardiology

Mironov N.Yu.

Chazov National Medical Research Centre of Cardiology

Vlodzyanovskiy V.V.

Chazov National Medical Research Centre of Cardiology

Malkina T.A.

Chazov National Medical Research Centre of Cardiology

Golitsyn S.P.

Chazov National Medical Research Centre of Cardiology

Phase II clinical trial of refralon tablets in patients with persistent atrial fibrillation and atrial flutter. The structure and plan of the study

Authors:

Yuricheva Yu.A., Belyaeva M.M., Dzaurova K.M., Krymukova M.A., Sokolov S.F., Mironov N.Yu., Vlodzyanovskiy V.V., Malkina T.A., Golitsyn S.P.

More about the authors

Journal: Russian Cardiology Bulletin. 2024;19(4‑2): 182‑187

DOI: 10.17116/Cardiobulletin202419042182

Read: 1443 times

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Table of contents

PHASE II CLINICAL TRIAL OF REFRALON TABLETS IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION AND ATRIAL FLUTTER. THE STRUCTURE AND PLAN OF THE STUDY
PHASE II CLINICAL TRIAL OF REFRALON TABLETS IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION AND ATRIAL FLUTTER. THE STRUCTURE AND PLAN OF THE STUDY

To cite this article:

Yuricheva YuA, Belyaeva MM, Dzaurova KM, et al. . Phase II clinical trial of refralon tablets in patients with persistent atrial fibrillation and atrial flutter. The structure and plan of the study. Russian Cardiology Bulletin. 2024;19(4‑2):182‑187. (In Russ.)
https://doi.org/10.17116/Cardiobulletin202419042182

Подписка 2026 Кардиологический вестник (Russian Cardiology Bulletin)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

Refralon (cavutilide) is a highly effective drug for intravenous administration to restore sinus rhythm in patients with atrial fibrillation (AF) and atrial flutter (AFl) of any duration. Phase I clinical trial of tablets described pharmacokinetic profile of this drug, dosages and safety of therapy. These data underlie phase II clinical trial protocol as a multiple-center randomized double-blind placebo-controlled trial. This study is devoted to evaluate efficacy and safety of refralon tablets at doses of 1 and 2 mg daily to prevent AF/AFl recurrence after cardioversion of persistent form throughout 6-month therapy. This report is the first announcement of the study protocol (ClinialTrials.gov Identifier: NCT06540352).

Keywords:

class III antiarrhythmic drug
refralon
cavutilide
atrial fibrillation
atrial flutter
II phase trial
QT interval

Authors:

Yuricheva Yu.A.

Chazov National Medical Research Centre of Cardiology

Belyaeva M.M.

Chazov National Medical Research Centre of Cardiology

Dzaurova K.M.

Chazov National Medical Research Centre of Cardiology

Krymukova M.A.

Chazov National Medical Research Centre of Cardiology

Sokolov S.F.

Chazov National Medical Research Centre of Cardiology

Mironov N.Yu.

Chazov National Medical Research Centre of Cardiology

Vlodzyanovskiy V.V.

Chazov National Medical Research Centre of Cardiology

Malkina T.A.

Chazov National Medical Research Centre of Cardiology

Golitsyn S.P.

Chazov National Medical Research Centre of Cardiology

Received:

30.09.2024

Accepted:

21.10.2024

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References:

  1. Arakelyan M.G., Bockeria L.A., Vasilieva E.Yu., Golitsyn S.P., Golukhova E.Z., Gorev M.V., Davtyan K.V., Drapkina O.M., Kropacheva E.S., Kuchinskaya E.A., Lajovich L.Yu., Mironov N.Yu., Mishina I.E., Panchenko E.P., Revishvili A.S., Rzayev F.G., Tatarsky B.A., Utsumueva M.D., Shakhmatova O.O., Shlevkov N.B., Shpektor A.V., Andreev D.A., Artyukhina E.A., Barbarash O.L., Galyavich A.S., Duplyakov D.V., Zenin S.A., Lebedev D.S., Mikhailov E.N., Novikova N.A., Popov S.V., Filatov A.G., Shlyakhto E.V., Shubik Yu.V. 2020 Clinical guidelines for Atrial fibrillation and atrial flutter. Russian Journal of Cardiology. 2021;26(7):4594. (In Russ.). https://doi.org/10.15829/1560-4071-2021-4594
  2. Golitsyn S.P., Panchenko E.P., Kropacheva E.S., Layovich L.Yu., Maikov E.B., Mironov N.Yu., Shakhmatova O.O. Eurasian clinical recommendations on diagnosis and treatment of atrial fibrillation. Eurasian heart journal. 2019;(4):4-85(In Russ.). https://doi.org/10.38109/2225-1685-2019-4-4-85
  3. Mironov N.Yu., Yuricheva Yu.A., Vlodzyanovskiy V.V., Sokolov S.F., Dzaurova K.M., Golitsyn S.P., Shubik Yu.V., Berman M.V., Medvedev M.M., Rivin A.E., Parkhomchuk D.S., Barybin A.E., Balandin D.A., Batalov R.E., Terekhov D.S., Evstifeev I.V., Kildeev I.R., Pyataeva O.V., Zenin S.A. Safety and Effectiveness of Pharmacologic Conversion of Atrial Fibrillation and Flutter: Results of Multicenter Trial. Part I: Study Rationale, Design and Assessment of Effectiveness. Rational Pharmacotherapy in Cardiology. 2021;17(2):193-199. (In Russ.). https://doi.org/10.20996/1819-6446-2021-03-05
  4. Mironov N.Yu., Vlodzyanovskiy V.V., Yuricheva Yu.A., Sokolov S.F. et al. Safety and effectiveness of electrical and pharmacological cardioversion in persistent atrial fibrillation. Part II: assessment of safety. Rational Pharmacotherapy in Cardiology. 2018;14(5):826-830 (in Russ.). https://doi.org/10.20996/1819-6446-2021-10-06
  5. Golitsyn, S.P., Panchenko, E.P., Kropacheva, E.S. et al. Eurasian clinical recommendations on diagnosis and treatment of atrial fibrillation. Eurasian heart journal. 2019;(4):4-85. (in Russ.). Valembois L, Audureau E, Takeda A, Jarzebowski W, Belmin J, Lafuente-Lafuente C. Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database and Systematic Reviews. 2019;9(9):CD005049. https://doi.org/10.1002/14651858.CD005049.pub5
  6. Yuricheva Yu.A., Dzaurova K.M., Beliaeva M.M., Mironov N.Yu., Sokolov S.F., Sherina T.A., Golitsyn S.P. The results of I phase clinical study of class III antiarrhythmic drug, tablet form. The Siberian Journal of Clinical and Experimental Medicine. 2023;38(4):141-150 (in Russ.). https://doi.org/10.29001/2073-8552-2023-38-4-141-150
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