Clinical trial • Cardiology
AMIODARONE HYDROCHLORIDE for Atrial fibrillation
Clinical trial of AMIODARONE HYDROCHLORIDE for Atrial fibrillation.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Atrial fibrillation
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-06-2024
- First CTIS Authorization Date
- 30-08-2024
Trial design
Randomised, open-label, two arms described as 'long pattern' and 'short pattern' corresponding to a one-month amiodarone impregnation regimen (long pattern) versus a 5-day amiodarone regimen (short pattern). specific per-arm doses or schedules are not stated in the record.-controlled trial in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Two arms described as 'Long pattern' and 'Short pattern' corresponding to a one-month amiodarone impregnation regimen (Long pattern) versus a 5-day amiodarone regimen (Short pattern). Specific per-arm doses or schedules are not stated in the record.
- Target Sample Size
- 130
Eligibility
Recruits 130 Vulnerable populations not selected. Participants must be ≥18 years old and able to sign informed consent. No procedures for assent or consent for minors or other vulnerable groups are described..
- Pregnancy Exclusion
- Women of childbearing potential unwilling to use contraceptive measures
- Vulnerable Population
- Vulnerable populations not selected. Participants must be ≥18 years old and able to sign informed consent. No procedures for assent or consent for minors or other vulnerable groups are described.
Inclusion criteria
- {"criterion_text":"- INCLUSION CRITERIA: 1.Patients ≥18 years old.\n- 2.Persistent atrial fibrillation (≥ 7 days duration).\n- 3.Referred for elective electrical cardioversion.\n- 4.\tSigning of the informed consent"}
Exclusion criteria
- {"criterion_text":"- EXCLUSION CRITERIA: 1.\tNeed of urgent electrical cardioversion\n- 2.Mean Heart rate <50 bpm\n- 3.Planned ablation < 1 month after ECV.\n- 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)\n- 5.Atrial fibrillation post-cardiac surgery\n- 6.New York Heart Association (NYHA) Class IV heart failure\n- 7.Left ventricular ejection fraction (LVEF) ≤30%\n- 8.History of thyroid disease (hyperthyroidism or hypothyroidism)\n- 9.Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)\n- 10.Allergy, intolerance, or known hypersensitivity to study medication\n- 11.Women of childbearing potential unwilling to use contraceptive measures\n- 12.Participation in another clinical trial involving investigational drugs\n- 13.Life expectancy less than 12 months\n- 14.Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Efficacy of amiodarone in reversion to sinus rhythm before electrical cardioversion in persistent atrial fibrillation.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1) time from initiation of amiodarone to reversion to sinus rhythm; 2) maintenance of sinus rhythm during the month after electrical cardioversion.","definition_or_measurement_approach":"Secondary objectives state: (1) identify days from initiation of pre-ECV amiodarone to reversion to SR using a mobile device paired to the mobile phone; (2) maintenance of sinus rhythm measured during the month after electrical cardioversion."}
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 19
- Consent Approach
- Participants (≥18 years) must sign informed consent. A subject information and informed consent form document is listed for publication. Inclusion criteria require 'Signing of the informed consent'. Spanish translations of trial text are present; no assent procedures for minors are described.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 130
Spain
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 50
- Number Of Sites
- 3
- Number Of Participants
- 130
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiologia
- Contact Person Name
- Jose Maria Guerra
- Contact Person Email
- jguerra@santpau.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Cardiologia
- Contact Person Name
- Roger Villuendas Sabaté
- Contact Person Email
- rogervilluendas@hotmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiologia
- Contact Person Name
- Moises Rodriguez Mañero
- Contact Person Email
- moirmanero@gmail.com
Sponsor
Primary sponsor
- Full Name
- Institut D Investigacio Sanitaria Pere Virgili
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"","full_name":"Societat Catalana de Cardiologia","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"Sociedad Española de Cardiología","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Trangorex 200 mg comprimidos
- Active Substance
- AMIODARONE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 800 mg (max daily dose amount)
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