ot applicable

Phase 1

• Conditions: Restoration of sinus rhythm in patients with recent AF onset; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-004865-11-GR
• Lead Sponsor: Win Medica Pharmaceuticals S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

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

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 <55%)
4. Hypotension (systolic blood pressure <100mmHg)
5. Previous treatment with ranolazine within previous 48 hours.
6. Atrial fibrillation disorder [(2nd degree atrioventricular block, biceps block (RBBB + LAH or RBBB + LPH), or left arm block (LBBB)}, or absent sinus syndrome
pacemaker,
7. Hemodynamically intolerant AF
8. Creatinine clearance less than or equal to 30ml / min
9. Moderate or severe hepatic impairment
10. Extended QTc interval (corrected QT> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified