2025-525121-13-00招募中4 期
Randomized Evaluation of fleCAinide safety vs. STandard of care in patients with coronary artery disease and Atrial Fibrillation (ReCAST AF).
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 988
- 试验地点
- 28
- 主要终点
- A composite safety outcome including the following adverse events of interest: (1) All-cause mortality; (2) Severe adverse events leading to drug discontinuation; and (3) Unscheduled hospitalisation for heart failure or acute coronary syndrome
研究概览
简要总结
To demonstrate that, in patients with atrial fibrillation and stable coronary artery disease, the safety profile of flecainide for rhythm control is non-inferior to that of class III antiarrhythmic drugs, as measured by the primary composite endpoint over a minimum follow-up of 1 year.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- •Non-permanent atrial fibrillation or ectopic atrial tachycardia with rhythm control strategy, documented on any modality in the 1 year preceding the consent date
- •Stable coronary artery disease without argument of ischemia, defined as: a. Prior percutaneous coronary intervention; OR b. Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR c. Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR d. Coronary CT scan showing coronary stenosis CAD-RADS stage ≥ 3 on, including CAD-RADS stages 4 and 5 in the absence of ischemia on exercise testing, myocardial perfusion imaging (MIBI), stress cardiac MRI, or fractional flow reserve.
- •Left ventricular ejection fraction ≥ 45% documented on any imaging modality
排除标准
- •Significant chronic kidney disease (eGFR <40 mL/min)
- •Life expectancy less than 1 year
- •NYHA class III or IV congestive heart failure
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- •Inability to provide written informed consent, including decision-making incapacity due to cognitive impairment or other medical or psychiatric conditions that preclude adequate understanding of the study and its procedures.
- •Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- •Active treatment with amiodarone
- •History of intolerance of flecainide or both sotalol and amiodarone
- •Unstable angina or inducible ischemia on exercise stress testing, myocardial perfusion imaging, stress cardiac MRI, or fractional flow reserve performed for clinical indications
- •Baseline QRS duration ≥ 120 ms, unless a functioning pacemaker is present
- •Known channelopathy, including Brugada syndrome, long QT syndrome,…
- •Baseline corrected QT interval (Fridericia) ≥ 500 ms
- •Pre-existing advanced AV block (second-, or third-degree)
- •Pre-existing sick sinus syndrome or sinus bradycardia <50 bpm
- •Clinically significant uncorrected hypokalemia or hypomagnesemia before initiation of trial treatment.
- •Evidence or history of thyroid dysfunction contraindicating amiodarone use, where amiodarone would be prescribed as standard of care treatment.
- •Hypersensitivity to the active substances or any excipients.
- •Contra-indication to AV-slowing agents, including beta-blockers, diltiazem or verapamil
- •Atrial fibrillation due to reversible cause
- •Active intracardiac thrombus
- •Acute coronary syndrome during the 3-month period preceding the consent date
- •Cardiac surgery, including coronary artery bypass surgery, during the 3-month period preceding the consent date or planned at a future date at the time of consent
- •Moderate or severe congenital heart disease as per 2020 ESC guidelines
- •Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
研究组 & 干预措施
Flecainide Retard EG 150 mg harde capsules met verlengde afgifte, Flecainide Retard EG 100 mg harde capsules met verlengde afgifte, Flecainide Retard EG 200 mg harde capsules met verlengde afgifte
Test
干预措施: Flecainide Retard EG 200 mg harde capsules met verlengde afgifte (Drug)
Amiodarone EG 200 mg tabletten
Comparator
干预措施: Amiodarone EG 200 mg tabletten (Drug)
Flecainide Retard EG 150 mg harde capsules met verlengde afgifte, Flecainide Retard EG 100 mg harde capsules met verlengde afgifte, Flecainide Retard EG 200 mg harde capsules met verlengde afgifte
Test
干预措施: Flecainide Retard EG 150 mg harde capsules met verlengde afgifte (Drug)
Sotalol Sandoz 160 mg tabletten, Sotalol Sandoz 80 mg tabletten
Comparator
干预措施: Sotalol Sandoz 80 mg tabletten (Drug)
Flecainide Retard EG 150 mg harde capsules met verlengde afgifte, Flecainide Retard EG 100 mg harde capsules met verlengde afgifte, Flecainide Retard EG 200 mg harde capsules met verlengde afgifte
Test
干预措施: Flecainide Retard EG 100 mg harde capsules met verlengde afgifte (Drug)
Sotalol Sandoz 160 mg tabletten, Sotalol Sandoz 80 mg tabletten
Comparator
干预措施: Sotalol Sandoz 160 mg tabletten (Drug)
结局指标
主要结局
A composite safety outcome including the following adverse events of interest: (1) All-cause mortality; (2) Severe adverse events leading to drug discontinuation; and (3) Unscheduled hospitalisation for heart failure or acute coronary syndrome
A composite safety outcome including the following adverse events of interest: (1) All-cause mortality; (2) Severe adverse events leading to drug discontinuation; and (3) Unscheduled hospitalisation for heart failure or acute coronary syndrome
次要结局
- Individual components of the primary safety endpoint
- Freedom from fast atrial arrhythmia post-treatment (clinical recurrence of AF)
- Major adverse cardiovascular events (MACE): cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke
- Incidence of catheter ablation for AF during follow-up
- Total number of days of cardiovascular hospitalisation
- All adverse and serious adverse events (frequency and severity, proportion of participants experiencing at least one AE/SAE, specific drug-related adverse events)
- Changes in cardiac function from baseline to follow-up (left ventricular ejection fraction, global longitudinal strain, left atrial volume index)
- Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP) from baseline
- Change in QTc interval (ms) and QRS duration (ms) from baseline.
- Patient-reported outcome measures, including: Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire; EuroQoL-5 dimension health utility index (EQ-5D-5L); Short Form-12 (SF-12) health survey; EHRA symptom score; Work Productivity and Activity Impairment (WPAI) questionnaire
- Economic evaluation with within-trial healthcare resource utilization between the two treatment arms
研究者
Prof. Dr. Joris Ector
Scientific
UZ Leuven
研究点 (28)
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