??a p???pt???, p????e?t????, t??a??p???µ???, ??????? d???µ? ??a t?? asf??e?a ?a? t?? ap?te?esµat???t?ta t?? F?e?a???d?? ??a?t? t?? ?µ??da????? ??a t?? ?a?d??a??ta?? t?? pa????sµ???? ???p???? ?a?µa????? st? ?µ?µa ?pe????t?? ?e??stat???? se as?e?e?? µe stefa??a?a ??s? ????? ?p??e?p?µe?? ?s?a?µ?a ?a? ???sµa e????s?? > 35%(FLECA-ED)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002589-34-GR

Enrollment

200

Registered

2022-10-03

Start date

2022-12-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

?a?d??a??ta?? t?? pa????sµ???? ???p???? µa?µa????? st? ?µ?µa ?pe????t?? ?e??stat???? se as?e?e?? µe stefa??a?a ??s? ????? ?p??e?p?µe?? ?s?a?µ?a ?a? ???sµa e????s?? > 35%. MedDRA version: 20.0 Level: LLT Classification code 10003661 Term: Atrial fibrillation paroxysmal System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Flecardia Product Name: FLECARDIA ???s?µ? ?????µa Pharmaceutical Form: Injection Trade Name: ANGORON ???s?µ? ?????µa Product Name: ANGORON INJ.SOL 150MG/3ML AMP BTX6AMPX3ML Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ?????a: 18-85 et??. 2. ?a????sµ??? ??, te?µ????µ??? µe ??G 12–apa?????, ef?s?? p?????ta? ??a ap? ta ??t???: o ??a??? ?? se d??st?µa µ????te?? t?? 48 ???? ap? t? st??µ? p??s??e?s?? st? ???, a?e?a?t?t?? ????? a?t?p??t???? a?????. o ??a??? ?? se d??st?µa µ????te?? t?? 7 ?µe??? ap? t? st??µ? p??s??e?s?? st? ???, ?a? ???? a?t?p??t???? a????? ??a t??????st?? 30 ?µ??e? 3. ?st????? stefa??a?a? ??s?? ????? ?p??e?p?µe?? ?s?a?µ?a, ?a??????µe?? ap? ??a ap? ta pa?a??t? ???t???a: o ?/? as?e??? ?peß???? se a??e??p?ast??? e?t?? e??? ?t???. o ?/? as?e??? ?peß???? se a??t?stefa??a?a pa???aµ?? e?t?? t?? te?e?ta??? 3 et??. o ?/? as?e??? ?peß???? e?t?? e??? ?t??? se ape?????st??? d???µas?a ??p?s?? ? ?p??a ?ta? a???t???, ?a? ep?p??s??t??: 4. ?/? as?e??? ?peß???? se a??e??p?ast??? se d??st?µa µe?a??te?? t?? e??? ?t???, ? 5. ?/? as?e??? ?peß???? se a??t?stefa??a?a pa???aµ?? se d??st?µa µe?a??te?? t?? 3 et??, ? 6. ?/? as?e??? ??e? ?st????? st???s?? stefa??a??? a??e??? > 60% ????? t? d?e????e?a epa?a??e??s?? 7. ???sµa e????s?? > 35% (te?µ????µ??? µe ????a?d?????f?µa st? ??? ? ????a?d?????f?µa e?t?? e??? ?t???) 8. ?p??e??aµµ??? ??t?p? s??a??es?? ?at?p?? e??µ???s?? 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 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. ?e ß?s? t? ??G st? ???: o ???p???? ?te????sµ?? o ???sfata ?ata?e??aµµ???? ?p???e?sµ?? ???ste??? S?????? o ???sfata ?ata?e??aµµ???? ?p???e?sµ?? ?e???? S?????? µe d????e?a QRS > 150 ms 2. ?p??ad?p?te p??????µe?? 24??? pa?a???????s? ??G µe > 720 p???µ??f???? PVCs / 24???, ? µ? eµµ????sa ?????a?? ta???a?d?a. 3. ?p??s?a ?st?????? Stefa??a?a? ??s?? 4. ?µf?a?µa t?? µ???a?d??? µe a??spas? t?? d?ast?µat?? ST 5. ?µf?a?µa t?? µ???a?d??? ????? a??spas? t?? ST d?ast?µat?? o ??? ? t??p????? p?? ?aµß??eta? ?at? t?? t0 e??a? p??? ap? t? ???t???? «?aµ???», ?p?? a?af??eta? st?? p??a?a µe ta e?d??? ??a t? µ???d? ep?peda ????? ap???p??. o ??? ? ?(t??p?????? 1 ??a?) e??a? p??? ap? t? a?t?st???? ???? st?? p??a?a t?? e?d???? ??a t? µ???d? ep?p?d?? ????? ap???p??. 6. ?sta??? st?????? (?s?a?µ?a t?? µ???a?d??? se ??eµ?a ? se e????st? p??sp??e?a, ap??s?a ??e?a? ß??ß??/?????s?? t?? µ???a?d?a??? ??tt????) 7. G??st? ?p??e?p?µe?? ?s?a?µ?a: o Tet??? d???µas?a ??p?s?? o ????t??? d???µas?a ??p?s?? se d??st?µa µe?a??te?? t?? e??? ?t??? se pe??pt?s? p??: 8. ?/? as?e??? ?peß???? se a??e??p?ast??? se d??st?µa µe?a??te?? t?? e??? ?t???, ? 9. ?/? as?e??? ?peß???? se a??t?stefa??a?a pa???aµ?? se d??st?µa µe?a??te?? t?? 3 et??, ? 10. ?/? as?e??? ??e? ?st????? µ? epa?a??e???µe??? st???s?? stefa??a??? a??e??? ??? t?? 60%. 11. ?st????? ????? stefa??a??? s??d??µ?? ?at? t? te?e?ta?? ?t?? 12. S?ßa?? a??t??? st???s? (µ?s? d?af??? p?es?? > 40 mmHg, AVA < 1 cm/m2) 13. S?ßa?? ?????a ?ef???? ??s?? (st?d?? = 4) 14. S?ßa?? s?st?µat??? ??s??, s?µpe???aµßa??µ???? ?e?p?asµat???? ??s?? ?p? ?p??ad?p?te a?t??e?p?asµat??? a????, ?pat???? a?ep???e?a?, ???µ???? µe p??et?. 15. ???s? t?? st?at?????? «pill in the pocket» (??p? st?? ts?p?) µe f?e?a???d? (max 200 mg) ? p??pafa????? (max 600 mg) e?t?? 6 ???? p??? ap? t?? ep?s?e?? st? ???. 16. ??sa?e??a ? ???st? a??e???a st? f?e?a???d? ?a? t?? aµ??da???? 17. ????µ?s??? ?/?a? ???asµ?? 18. S?µµet??? se ?p??ad?p?te ???? ??????? d???µ?. 19. ???sd???µ? ???? µ????te?? ap? 1 ?t??. 20. ??at???????/?, a???a???/? ? ap????µ??/? as?e??? ?a a???????se? t?? apa?t??µe?e? d?ad??as?e? t?? p??t???????

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. ?a ap?de???e? ? ?pe???? t?? f?e?a???d?? ??a?t? t?? aµ??da????? st?? ep?t??? a??ta?? t?? pa????sµ???? ?? se f?eß???µß??? ???µ? st? ??? 2. ?a ap?de???e? ? µ?-?at?te??t?ta t?? asf??e?a? t?? f?e?a???d?? ??a?t? t?? aµ??da?????. ;Secondary Objective: ?a ap?de???e? ? ?pe???? t?? f?e?a???d?? ??a?t? t?? aµ??da????? sta e???: 1. t? µe??s? t?? a?????? ??a e?sa????? ap? t? ??? ???? ?? 2. t? ????? p?? apa?te?ta? ??a t?? ep?t??? ap??at?stas? t?? f?eß???µß???? ???µ?? 3. t? µe??s? t?? a?????? ??a ??e?t???? ?a?d??a??ta?? ;Primary end point(s): 1. ? s????t?ta ep?t????? µetat??p?? se f?eß???µß??? ???µ? 2. ? s??d?asµ??? s????t?ta t?? PVCs, t?? NSVT, t?? SVT, t?? ß?ad??a?d?a? < 40 bpm, ?a? t?? s?st?????? a?t???a??? p?es?? < 90 mmHg ;Timepoint(s) of evaluation of this end point: 1. ?p? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 2. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e?	—

Measure

Time frame

Main Objective: 1. ?a ap?de???e? ? ?pe???? t?? f?e?a???d?? ??a?t? t?? aµ??da????? st?? ep?t??? a??ta?? t?? pa????sµ???? ?? se f?eß???µß??? ???µ? st? ??? 2. ?a ap?de???e? ? µ?-?at?te??t?ta t?? asf??e?a? t?? f?e?a???d?? ??a?t? t?? aµ??da?????. ;Secondary Objective: ?a ap?de???e? ? ?pe???? t?? f?e?a???d?? ??a?t? t?? aµ??da????? sta e???: 1. t? µe??s? t?? a?????? ??a e?sa????? ap? t? ??? ???? ?? 2. t? ????? p?? apa?te?ta? ??a t?? ep?t??? ap??at?stas? t?? f?eß???µß???? ???µ?? 3. t? µe??s? t?? a?????? ??a ??e?t???? ?a?d??a??ta?? ;Primary end point(s): 1. ? s????t?ta ep?t????? µetat??p?? se f?eß???µß??? ???µ? 2. ? s??d?asµ??? s????t?ta t?? PVCs, t?? NSVT, t?? SVT, t?? ß?ad??a?d?a? < 40 bpm, ?a? t?? s?st?????? a?t???a??? p?es?? < 90 mmHg ;Timepoint(s) of evaluation of this end point: 1. ?p? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 2. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e?

—

Secondary

Measure	Time frame
Secondary end point(s): 1. ? s????t?ta e??t????? ap? t? ??? se f?eß???µß??? ???µ? 2. ? s????t?ta ep?t????? µetat??p?? se f?eß???µß??? ???µ? 3. ?????? ??? t?? ap??at?stas? t?? f?eß???µß???? ???µ?? 4. ? s????t?ta a?????? ??a ??e?t???? ?a?d??a??ta?? 5. ? s????t?ta epa?a-p??s??e?s?? st? ??? ???? ???p???? µa?µa????? 6. ? s????t?ta a????µ???: ep?ß????s? ap? PVCs, epe?s?d?a NSVT, epe?s?d?a SVT 7. ? s????t?ta, ? ßa??t?ta ?a? ? t?p?? t?? ?S ;Timepoint(s) of evaluation of this end point: 1. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 2. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 24 ??e?, 24??? pa?a???????s? Holter 3. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 4. ??a d??st?µa ??? 24 ??e? 5. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ?????a? ??a d??st?µa ??? 30 ?µ??e? 6. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 24 ??e? 7. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 30 ?µ??e?	—

Measure

Time frame

Secondary end point(s): 1. ? s????t?ta e??t????? ap? t? ??? se f?eß???µß??? ???µ? 2. ? s????t?ta ep?t????? µetat??p?? se f?eß???µß??? ???µ? 3. ?????? ??? t?? ap??at?stas? t?? f?eß???µß???? ???µ?? 4. ? s????t?ta a?????? ??a ??e?t???? ?a?d??a??ta?? 5. ? s????t?ta epa?a-p??s??e?s?? st? ??? ???? ???p???? µa?µa????? 6. ? s????t?ta a????µ???: ep?ß????s? ap? PVCs, epe?s?d?a NSVT, epe?s?d?a SVT 7. ? s????t?ta, ? ßa??t?ta ?a? ? t?p?? t?? ?S ;Timepoint(s) of evaluation of this end point: 1. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 2. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 24 ??e?, 24??? pa?a???????s? Holter 3. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 6 ??e? 4. ??a d??st?µa ??? 24 ??e? 5. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ?????a? ??a d??st?µa ??? 30 ?µ??e? 6. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 24 ??e? 7. ap? t? st??µ? t?? ??a???? ??????s?? t?? fa?µ???? ?a? ??a d??st?µa ??? 30 ?µ??e?

—

Countries

Greece

Contacts

Public ContactG??ta ???f???

WinMedica S.A.

g.koufaki@winmedica.gr+302107488821

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026