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Comparison of the effectiveness of IntraVenous FLECainide plus oral ranolazine versus intravenous flecainide alone in the cardioversion of recent onset atrial fibrillation - a randomized, prospective, multicentre, open-label study, the IV-FLEC study.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514677-22-00
Enrollment
210
Registered
2024-09-09
Start date
2023-03-23
Completion date
2025-05-30
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restoration of sinus rhythm in patients with recent AF onset

Brief summary

Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 3 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.

Detailed description

Time interval from initiation of treatment with IV flecainide and PO ranolazine versus IV flecainide monotherapy to restoration of sinus rhythm in patients with recent onset (<48 hours) AF, Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 6 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.

Interventions

Sponsors

Win Medica Pharmaceutical A.E.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 3 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.

Secondary

MeasureTime frame
Time interval from initiation of treatment with IV flecainide and PO ranolazine versus IV flecainide monotherapy to restoration of sinus rhythm in patients with recent onset (<48 hours) AF, Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 6 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026