A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study of AP30663 Given Intravenously for Cardioversion in Patients With Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 15
- 主要终点
- Percentage of Participants Who Converted From Atrial Fibrillation (AF) Within 90 Minutes From Start of Infusion and Subsequently Had no AF Recurrence Within 1 Minute of Conversion From AF
研究概览
简要总结
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for cardioversion of AF
- •Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization
- •Adequate anticoagulation according to international and/or national guidelines
排除标准
- •Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit
- •History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator.
- •Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization
- •Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Part 1: AP30663
Participants will receive single dose of AP30663.
干预措施: AP30663 (Drug)
Part 1: Placebo
Participants will receive placebo matched to AP30663.
干预措施: Placebo (Drug)
Part 2: AP30663
Participants will receive a single dose of one of the multiple dose levels of AP30663.
干预措施: AP30663 (Drug)
Part 2: Placebo
Participants will receive placebo matched to AP30663.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Converted From Atrial Fibrillation (AF) Within 90 Minutes From Start of Infusion and Subsequently Had no AF Recurrence Within 1 Minute of Conversion From AF
时间窗: Within 90 minutes from the start of infusion (Day 1)
The 12-lead Holter monitoring equipment was used to monitor heart rate and its rhythm. Electrocardiogram (ECG) was performed in a standardized manner after the participant had rested in the semi-supine position for at least 5 minutes. Conversion from AF to normal sinus rhythm within 90 minutes from start of infusion was determined by the investigator and documented with a rhythm strip confirming conversion. Percentages were based on "number of participants converted from atrial fibrillation and absence of recurrence of AF within 1 minute of conversion" divided by "total number of participants" \*100 in each treatment group. Analysis was performed based on Bayesian model.
次要结局
- Time to Conversion From Atrial Fibrillation From Start of Infusion(From start of infusion (Day 1) up to Day 2)
- Percentage of Participants With Relapse of AF Within 5 Minutes (IRAF) After Pharmacological or Direct Current (DC) Cardioversion(Within 5 minutes after cardioversion (Day 1))
- Maximum Observed Peak Plasma Concentration (Cmax) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)
- Changes From Baseline in Fridericia's Correction of QT Interval (ΔQTcF) Interval Data Over Time(Baseline, 15 minutes, 45 minutes, 2 hours, 8 hours and 24 hours post-dose)
- Area Under the Concentration Time Curve From Pre-dose Concentration up to 30 Minutes (AUC0-0.5) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30 minutes post-infusion)
- Area Under the Concentration-Time Curve From Pre-dose (Zero) Through Concentration to Infinity (AUC0-inf) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs(From start of infusion (Day 1) up to follow-up (Day 35))
- Percentage of Participants With Sinus Rhythm (SR) at 3 Hours, 24 Hours and Day 30 After Start of Infusion(At 3 hours, 24 hours and Day 30 after start of Infusion (Day 1))
- Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUC0-t) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)
- Time to Reach Peak Plasma Concentration (Tmax) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)
- Terminal Half Life of (T1/2) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)
- Elimination Rate Constant (Kel) of AP30663(Baseline (pre-infusion) and at 5, 15, 25, 30, 45 minutes, 1 hour, 1.5 hours, 4 hours, 8 hours and 24 hours post-infusion)