Restoration of sinus rhythm in patients with recent AF onset
Conditions
Interventions
Trade Name: FLECARDIA
Product Name: FLECARDIA
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: FLECAINIDE ACETATE
CAS Number: 54143-56-5
Concentration unit: mg/ml milligram(s)
Sponsors
Win Medica Pharmaceuticals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients can only be included in the study if they meet all of the following Criteria: 1. Patients aged =18 years 2. Patients with electrocardiographically confirmed AF, with recent onset (self-reported onset of arrhythmia within 48 hours of starting medication reorganization). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the have the following criteria: 1. Coronary heart disease and / or significant structural heart disease 2. Cardiogenic shock 3. Heart failure, or reduced systolic function left ventricle (ejection fraction 460ms) 11. Recent treatment with antiarrhythmic drugs category Ic within the previous 24 hours or with amiodarone within the previous 6 months 12. Co-administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, klarithromycin, telithromycin, nefazodone) 13. Known Brugada syndrome 14. Pregnant or breastfeeding women 15. Hypersensitivity to flecainide (flecainide acetate) or to ranolazine or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to compare the effectiveness of the combined antiarrhythmic therapy with flecainide IV and ranolazine PO versus monotherapy with flecainide IV, in the restoration of sinus rhythm in patients with recent AF (<48 hours), which are suitable for drug reassignment and meet the inclusion and exclusion criteria. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the percentage of AF patients referred sinus rhythm within 3 hours after the start of the combined antiarrhythmic treatment with flecainide IV and PC ranolazine PC versus flecainide IV monotherapy. ;Timepoint(s) of evaluation of this end point: From baseline to the end of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Comparison of the mean (standard deviation) time from the start of treatment to restoration of sinus rhythm in the combined antiarrhythmic group treatment with flecainide IV and ranolazine PO versus flecainide IV monotherapy. 2. Percentage of patients with sinus rhythm recovery 6 hours after onset combined antiarrhythmic therapy with flecainide IV and ranolazine PO versus monotherapy with flecainide IV ;Timepoint(s) of evaluation of this end point: From baseline to the end of trial. | — |
Countries
Greece
Contacts
Public ContactGiota Koufaki
Win Medica Pharmaceuticals S.A.
Outcome results
None listed