2025-521377-14-00招募中2 期
Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 35
- 主要终点
- AF burden from week 2 to week 12.
研究概览
简要总结
To assess the effect of AP31969 on atrial fibrillation (AF) burden.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up (Visit 9)
- 盲法
- Double (Monitor, Analyst, Investigator, Carer, Subject)
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
- 是
入选标准
- •Willing and able to provide written informed consent.
- •Age 18 or older.
- •ECG documented diagnosis of AF.
- •AF history at screening indicating an expected AF burden of 1-90%.
- •If currently in AF, the episode must be of < 7 days duration at screening.
- •AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device.
- •Agreement to avoid non-trial related rhythm control intervention for the duration of the trial.
- •Willing to have a loop recorder implanted.
- •Female participants must not be pregnant or breastfeeding. Female participants of childbearing potential who have a fertile male sexual partner must agree to use highly effective contraception and not donate ova from 4 weeks prior to the first trial drug administration and until the follow-up visit. Male participants, if not surgically sterilized, who have a female sexual partner of childbearing potential, must agree to use a condom and not donate sperm from the screening visit until the follow-up visit.
排除标准
- •Prior AF ablation procedure (treatment that uses heat or cold energy to create tiny scars in an area of the heart).
- •Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to screening.
- •Use of QT-prolonging drug within 7 days prior to screening.
- •Significant cardiovascular events.
- •Use of a moderate or strong inhibitor of cytochrome P450 (CYP) 3A4 within 7 days prior to screening.
- •Received non-marketed or drug in a clinical trial within 30 days or 5 half-lives prior to screening.
- •Administration of AP31969 at any time prior to screening.
- •History of significant mental, renal or hepatic disorder, or other significant disease.
- •Planned or expected major cardiovascular or other procedure for the duration of the trial.
- •Cardiac pacing device, e.g., pacemaker.
- •Uncontrolled high blood pressure.
- •QTc interval > 450 ms for males and > 470 ms for females.
- •Heart failure.
- •Left ventricular ejection fraction (how much blood is pumped from the heart < 40%.
- •Clinically significant heart valve disease.
- •Personal or 1st degree family history of certain heart diseases.
- •History of drug addiction and/or alcohol abuse.
- •Any malignant cancer (except for in-situ non-melanoma skin cancer, breast ductal carcinoma in-situ and in-situ cervical cancer) within 2 years prior to screening.
- •QRS duration >120 ms at screening.
- •Sick sinus syndrome (heart rhythm disorder).
- •Atrioventricular block or complete bundle branch block (heart rhythm disorders).
- •Reduced kidney function.
- •Increase of liver enzymes.
- •Thyroid-stimulating hormone below 0.5 or above 5.0 mIU/L
- •Potassium below 3.5 or above 5.3 mmol/L.
结局指标
主要结局
AF burden from week 2 to week 12.
AF burden from week 2 to week 12.
次要结局
- • Number of AF episodes from week 2 to week 12 • Mean duration of AF episodes from week 2 to week 12 • Time to first AF episode > 5 hours (for participants in sinus rhythm [SR] at randomisation)
- • Change from baseline in Modified European Heart Rhythm Association (mEHRA) score at week 12
- • Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire at week 12 • Change from baseline in EQ-5D-5L score at week 12 • Patient Global Assessment of Change (PGI-C) score at week 12
- • Adverse events (AE) • Number of ventricular tachycardia episodes > 30 seconds of duration from week 0 to week 12 • Change from baseline in QTcF at week 12
研究者
Birgitte Vestbjerg
Scientific
Acesion Pharma ApS
研究点 (35)
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