NCT07405671招募中4 期
Randomized Evaluation of fleCAinide Safety Versus STandard of Care in Patients With Coronary Artery Disease and Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 988
- 试验地点
- 14
- 主要终点
- Composite safety outcome
研究概览
简要总结
The goal of this clinical trial is to learn whether the antiarrhythmic drug flecainide can be used as safely as standard rhythm-control drugs in people with atrial fibrillation (AF) and stable coronary artery disease (CAD). The study includes adults aged 18 years and older who have AF and known but stable coronary artery disease.
The main questions this study aims to answer are:
- Is treatment with flecainide as safe as standard rhythm-control drugs (sotalol or amiodarone) in this patient group?
- Does flecainide lead to similar or fewer serious side effects, hospitalisations, or deaths compared with standard treatment?
Researchers will compare patients treated with flecainide to patients treated with standard rhythm-control therapy (sotalol or amiodarone) to see whether flecainide is not worse in terms of safety outcomes.
Participants will:
- Be randomly assigned to receive either flecainide or standard rhythm-control medication
- Take the assigned medication as part of routine clinical care
- Attend regular follow-up visits at the hospital and have additional follow-up by telephone
- Undergo routine heart tests such as electrocardiograms and echocardiography
- Complete questionnaires about symptoms, quality of life, and daily functioning
This study follows patients for at least one year and collects information on safety, heart rhythm outcomes, quality of life, and healthcare use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
- •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, defined as:
- •Prior percutaneous coronary intervention; OR
- •Prior revascularised ACS or coronary artery bypass surgery > 3 months at enrolment; OR
- •Invasive coronary angiography demonstrating coronary atherosclerosis, defined as ≥50% diameter stenosis in at least one major epicardial coronary artery; OR
- •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.
- •LVEF ≥ 45% documented on any imaging modality*
排除标准
- •LVEF < 45%
- •NYHA class III or IV congestive heart failure
- •Active treatment with amiodarone
- •History of intolerance of flecainide or both sotalol and amiodarone
- •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.
- •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
- •Baseline corrected QT interval (Fridericia) ≥ 500 ms 11 Pre-existing advanced AV block (second-, or third-degree)
- •12. Pre-existing sick sinus syndrome or sinus bradycardia <50 bpm
- •Known channelopathy
- •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)
- •Significant chronic kidney disease (eGFR <40 mL/min)
- •Life expectancy less than 1 year
- •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.
- •25. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
研究组 & 干预措施
Flecainide
Experimental
Flecainide, a class Ic anti-arrhythmic drug.
干预措施: flecainide (Drug)
Sotalol or Amiodarone
Active Comparator
Class III anti-arrhythmic drug: sotalol or amiodarone as per physician preference.
干预措施: Sotalol or Amiodarone (Drug)
结局指标
主要结局
Composite safety outcome
时间窗: 1 year
The primary outcome measure is a composite safety outcome including all-cause mortality, severe adverse events leading to drug discontinuation, and unscheduled hospitalisation for heart failure or acute coronary syndrome. Each of these individual components is assessed as secondary outcome.
次要结局
- All-cause mortality(1 year)
- Severe adverse events leading to drug discontinuation(1 year)
- Unscheduled hospitalisation for heart failure or acute coronary syndrome(1 year)
- AF recurrence(1 year)
- Major adverse cardiovascular events(1 year)
- Catheter ablation(1 year)
- Cardiovascular hospitalisation duration(1 year)
- Treatment-related adverse events(1 year)
- Cardiac function - LVEF(3 months)
- NT-proBNP(3 months)
- QTc(1 year)
- Healthcare resource utilization(1 year)
- Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire(1 year)
- EuroQoL-5 dimension health utility index (EQ-5D-5L)(1 year)
- Short Form-12 (SF-12) health survey(1 year)
- EHRA symptom score(1 year)
- Work Productivity and Activity Impairment (WPAI) questionnaire(1 year)
研究者
研究点 (14)
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