Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
130
Countries
1
Sites
3
Atrial fibrillation
To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen
Key facts
- Sponsor
- Institut D Investigacio Sanitaria Pere Virgili
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 23 Jan 2025 → ongoing
- Decision date (initial)
- 2024-08-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Societat Catalana de Cardiologia; Sociedad Española de Cardiología
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To compare the efficacy of amiodarone in pre-ECV reversal to sinus rhythm in a one-month impregnation regimen versus a 5-day regimen
Secondary objectives 1
- 1) Identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; 2) To compare the joint efficacy in the reversion to SR pre-ECV and in the maintenance of SR at 1 month after ECV of a one-month pre-ECV amiodarone impregnation regimen vs a 5-day regimen
Conditions and MedDRA coding
Atrial fibrillation
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Multicenter randomized clinical trial "Multicenter randomized clinical trial to evaluate the cardioversion capacity of amiodarone pre-electrical cardioversion in persistent atrial fibrillation". Efficacy of amiodarone in reversion to sinus rhythm before electrical cardioversion in persistent atrial fibrillation.
|
Randomised Controlled | None | Long pattern: Long pattern Short pattern: Short pattern |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- INCLUSION CRITERIA: 1.Patients ≥18 years old. 2.Persistent atrial fibrillation (≥ 7 days duration). 3.Referred for elective electrical cardioversion. 4. Signing of the informed consent
Exclusion criteria 1
- EXCLUSION CRITERIA: 1. Need of urgent electrical cardioversion 2.Mean Heart rate <50 bpm 3.Planned ablation < 1 month after ECV. 4.Treatment with anti-arrhythmic drugs (IC, III) the last 7 days previous to inclusion (in the case of amiodarone on the 30 days previous to inclusion) 5.Atrial fibrillation post-cardiac surgery 6.New York Heart Association (NYHA) Class IV heart failure 7.Left ventricular ejection fraction (LVEF) ≤30% 8.History of thyroid disease (hyperthyroidism or hypothyroidism) 9.Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN) 10.Allergy, intolerance, or known hypersensitivity to study medication 11.Women of childbearing potential unwilling to use contraceptive measures 12.Participation in another clinical trial involving investigational drugs 13.Life expectancy less than 12 months 14.Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Efficacy of amiodarone in reversion to sinus rhythm before electrical cardioversion in persistent atrial fibrillation.
Secondary endpoints 1
- 1) time from initiation of amiodarone to reversion to sinus rhythm; 2) maintenance of sinus rhythm during the month after electrical cardioversion.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD430659 · Product
- Active substance
- Amiodarone Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 23800 mg milligram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- C01BD01 — AMIODARONE
- Marketing authorisation
- 48048
- MA holder
- SANOFI-AVENTIS, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut D Investigacio Sanitaria Pere Virgili
- Sponsor organisation
- Institut D Investigacio Sanitaria Pere Virgili
- Address
- Avinguda Del Doctor Josep Laporte 2
- City
- Reus
- Postcode
- 43204
- Country
- Spain
Scientific contact point
- Organisation
- Institut D Investigacio Sanitaria Pere Virgili
- Contact name
- Josep Maria Alegret Colomer
Public contact point
- Organisation
- Institut D Investigacio Sanitaria Pere Virgili
- Contact name
- Unidad de contratación de estudios de investigación
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 130 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital De La Santa Creu I Sant Pau
Cardiologia, Carrer De San Quinti 89, 08041, Barcelona
Hospital Germans Trias I Pujol
Cardiologia, Carretera Canyet 1a Planta, 08916, Badalona
Complexo Hospitalario Universitario De Santiago
Cardiologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-01-23 | 2025-01-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PERIVERSION 2023-507201-34-00 | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements 2023-507201-34-00 | 1 |
| Subject information and informed consent form (for publication) | CI 2023-507201-34-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Content labeling Amiodarone | 1 |
| Synopsis of the protocol (for publication) | SINOPSIS castellano 2023-507201-34-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-20 | Spain | Acceptable 2024-08-30
|
2024-08-30 |