BUDIODARONE TARTRATE for Non-permanent atrial fibrillation

Inclusion criteria

• {"criterion_text":"- CIED (Pacemaker or implantable loop recorder) Population o\tParticipants with a history of paroxysmal AF with LEAF lasting more than 5 hours recorded in their pacemaker within the 3 months before screening. o\tThe CIED data will be used to assess baseline AF eligibility criteria\n- Prior Therapy: Must have failed at least one prior therapy for AF including: •\tPrior AAD based upon physician judgement •\tPrior rate control drugs based upon physician judgement and continued symptoms •\tAF catheter ablation\n- AFSS: Must have an AFSS greater than 3.\n- CHA₂DS₂-VASc score of 1 or more for males and 2 or more for females and be on oral anticoagulant for at least 3 weeks prior to receiving the study medication.\n- NYHA Class I or II heart failure. However, those with NYHA Class II heart failure or a documented ejection fraction (EF) below 45% within the past two years must complete additional assessments\n- Able to understand study requirements and willing to follow instructions, attend all required study visits, and undergo all planned tests.\n- Elective Cardioversion Population (Persistent AF) o\tParticipants undergoing first-time elective cardioversion for persistent AF, or second-time cardioversion and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.\n- PAF Population Without Pacemakers or ILR where AF is quantified with wearable bands / patches o\tParticipants with paroxysmal AF who do not have a pacemaker or ILR and who have a history of frequent AF and LEAF, with a minimum CHA2DS2-VASc score of 1 or more for males and 2 or more for females and are on oral anticoagulant for at least 3 weeks prior to receiving the study medication. o\tThe patch data will be used to assess baseline AF eligibility criteria\n- Age: Adults between 18 and 80 years old.\n- Informed Consent: Must be capable and willing to provide written IC.\n- Women: Either postmenopausal for at least one year or surgically sterile; if premenopausal, must agree to use an approved method of contraception\n- Men: Must agree to use an approved method of contraception, such as condoms with spermicide, or have a sterile partner, throughout the 12-week treatment period\n- Proven paroxysmal atrial fibrillation (ECG, Holter monitor, cardiac patch, wearable or pacemaker diagnosis obtained by the clinical site or patient’s prior medical record documenting clear evidence of a diagnosis of PAF) or undergoing first-time elective cardioversion for persistent atrial fibrillation, or second-time cardioversion and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.\n- Baseline AF Criteria: To qualify for treatment, each participant must have during the 28-day baseline period an AFB greater than 5% and one of the following qualifying events: •\t2 continuous AF episodes (LEAF) of 5 hours or longer •\t2 rolling 24-hour periods in which cumulative AF duration is 5 hours or longer •\t1 continuous AF episode (LEAF) of 5 hours or longer plus 1 rolling 24-hour period in which cumulative AF duration is 5 hours or longer"}

Exclusion criteria

• {"criterion_text":"- Pregnancy/Contraception: Pregnant women, women intending to become pregnant, or women not practicing effective contraception (pharmacological or barrier methods).\n- Presence or history of congenital or primary cardiac channelopathies. This includes, but is not limited to: a.\tCongenital Long QT Syndrome (LQTS), including: i.\tRomano–Ward syndrome (autosomal dominant LQTS) ii.\tJervell and Lange–Nielsen syndrome (autosomal recessive LQTS with sensorineural deafness) iii.\tAndersen–Tawil syndrome (LQT7; KCNJ2 mutation) iv.\tTimothy syndrome (LQT8; CACNA1C mutation) b.\tBrugada syndrome (SCN5A-related sodium channelopathy) c.\tShort QT syndrome d.\tCatecholaminergic Polymorphic Ventricular Tachycardia (CPVT; RyR2 or CASQ2 mutations) e.\tLong–Ganong–Levine syndrome f.\tWolff–Parkinson–White syndrome or any form of pre-excitation due to an accessory pathway\n- Third-degree Atrioventricular Block without a functioning pacemaker.\n- Advanced His-Purkinje system disease or bifascicular block associated with syncope or presyncope without a functioning pacemaker.\n- Prior history of sustained ventricular tachycardia without an AICD or Torsades de Pointes.\n- Reversible causes of AF (e.g., hyperthyroidism, recent open- heart surgery, metabolic or electrolyte shift, or ongoing active ischemia).\n- Persistent AF (≥7 consecutive days or episodes >23 hours). Those presenting with persistent AF at screening are eligible if they are scheduled to undergo first-time elective cardioversion, or second-time cardioversion and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.\n- Recent treatment with rhythm control medications (Class I or III Singh-Vaughan Williams) within five half-lives before screening (rate control drugs permitted) and amiodarone within 3 months prior to screening.\n- Cardiac ablation procedures within 30 days of screening or participants who have scheduled an ablation procedure\n- Severe end-organ disease: a.\tEstimated glomerular filtration rate (eGFR) <30 mL/min at screening. b.\tAdvanced hepatic disease. c.\tAdvanced pulmonary disease. d.\tSevere psychiatric disorders, e.g., advanced dementia.\n- Known allergy or hypersensitivity to amiodarone or iodine.\n- Lactating Women: Breastfeeding women are excluded.\n- Termination of previous amiodarone treatment for severe toxicity.\n- Ongoing alcohol or substance abuse.\n- Anemia [hemoglobin <10 g/deciliter (dL) at screening].\n- Thrombocytopenia (platelet count <90,000/μL at screening).\n- Active/uncontrolled thyroid disease, unexplained thyroid function test abnormalities under investigation, history of thyroid malignancy/nodules, or conditions/medications affecting thyroid function, unless stable for ≥3 months with normal thyroid function tests (stable hypo/hyperthyroid patients on consistent therapy are eligible).\n- Any illness or condition judged by the investigator to compromise the participant’s safety during study drug administration.\n- Concomitant Risks: Participants with conditions or treatments that could: a.\tInterfere with the study's conduct. b.\tPose an unacceptable risk to safety, or compromise study data interpretation, such as: i.\tLife expectancy less than 2 years. ii.\tActive/suspected malignancy (except history of malignancy treated ≥2 years ago without evidence of recurrence). iii.\tSubstance abuse (alcohol/illicit drugs) in the last 12 months. iv.\tAny known or suspicion for relevant infectious diseases associated with clinical signs (e.g., TSE/Cruetzfield Jacobs disease, Viral Hepatitis, HIV/AIDS, Ebola, West Nile virus, Zika virus). v.\tThe participant is receiving analgesia via a continuous pain pump.\n- Investigational Drug Use: Recent treatment with investigational drugs within 30 days or 5 half-lives, whichever is longer.\n- Protocol Compliance: Subjects unable/unwilling to follow the study protocol.\n- NYHA Class 3 or 4 heart failure.\n- MI, ischemic stroke, or any clinically relevant venous thromboembolism within 3 months of screening.\n- Unstable angina, percutaneous transluminal coronary angioplasty (PTCA), or CABG within 3 months of screening.\n- Prolonged QTcF Interval (>500 ms with QRS ≤120 ms)."}

Primary endpoints

• {"endpoint_text":"- Safety: •\tIncidence of TEAE and treatment-emergent serious adverse events (TESAE). •\tIncidence of AESI •\tMortality and Clinical Morbidity Events: o\tDeath o\tResuscitated sudden cardiac death (SCD) including appropriate implanted cardiac defibrillator (ICD) discharge o\tCardiovascular hospitalization o\tStroke or another thromboembolic event •\tPhysical Exam assessments and abnormalities. •\tVital sign assessments and abnormalities. •\tClinical laboratory assessment and abnormalities. o\tThyroid functio","definition_or_measurement_approach":"Safety assessed by incidence counts of TEAEs, TESAEs, AESIs, specified mortality and clinical morbidity events (death, resuscitated SCD including ICD discharge, cardiovascular hospitalization, stroke/ thromboembolic events), physical exam findings, vital signs, and clinical laboratory assessments (including thyroid function)."}
• {"endpoint_text":"- Primary Efficacy: •\tProportion of participants that have no LEAF (uninterrupted episode of AF that is 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is greater than 5 hours) in the final month of treatment.","definition_or_measurement_approach":"Efficacy measured as the proportion of participants without LEAF in the final month of treatment. LEAF defined as an uninterrupted AF episode ≥5 hours or cumulative AF >5 hours in any rolling 24-hour period; assessed using device/patch/Holter/ECG monitoring during treatment."}
• {"endpoint_text":"- Exploratory Endpoint: •\tThe proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment","definition_or_measurement_approach":"Exploratory efficacy measured as the proportion of participants with no LEAF episodes ≥1 hour in final month of treatment, assessed by monitoring devices/ECG/patch data."}

Secondary endpoints

• {"endpoint_text":"- Change in percent AFSS during final month of treatment compared to baseline for multiple doses of budiodarone.\n- PGI-C during the final month of treatment.\n- Percent change in AFB during final month of treatment compared to baseline.","definition_or_measurement_approach":"Change in AFSS: percent change from baseline to final month by AFSS instrument; PGI-C: patient global impression of change during final month; Percent change in AFB: percent change in atrial fibrillation burden during final month vs baseline (device/patch/Holter-derived)."}

Other endpoints

• {"endpoint_text":"- The proportion of participants with no LEAF episodes lasting one hour or longer in the final month of budiodarone treatment","definition_or_measurement_approach":"Exploratory endpoint measured using monitoring devices/ECG/patch data to identify LEAF episodes ≥1 hour during the final month of treatment."}

Poland

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

30

Number Of Sites

13

Number Of Participants

100

Primary sponsor

Full Name

Xyra LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Amarex Clinical Research LLC

Responsibilities

11,13,6,8

Name

Global Medical Services Polska Sp. z o.o.

Responsibilities

1,12,2,5

Third parties

• {"country":"Poland","full_name":"Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi","duties_or_roles":["4"],"organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Poland","full_name":"Global Medical Services Polska Sp. z o.o.","duties_or_roles":["1","12","2","5"],"organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Amarex Clinical Research LLC","duties_or_roles":["11","13","6","8"],"organisation_type":"Pharmaceutical company"}