A Double-blind, Randomised, Placebo-controlled, Multicentre, Dose-escalating Study of AZD1305 Given Intravenously for Cardioversion of Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Dose-response Relationship for QTcF Interval of AZD1305
研究概览
简要总结
This study is being carried out to see which dose of AZD1305 is safe and effective in cardioverting atrial fibrillation into normal heart rhythm.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 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 Atrial Fibrillation, ie a correction of irregular heart rhythm to normal heart rhythm
- •Current episode of Atrial Fibrillation (ie irregular heart rhythm) lasting up to 3 months at randomisation
- •Adequate anticoagulation according to international guidelines (ACC/AHA/ESC, 2006) or national guidelines
排除标准
- •Potassium level below 3.8 mmol/L measured in serum or plasma
- •QTcF interval >440 ms
研究组 & 干预措施
1
AZD1305 iv infusion
干预措施: AZD1305 (Drug)
2
Placebo iv infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Dose-response Relationship for QTcF Interval of AZD1305
时间窗: At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).
QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date \& time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed
Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)
时间窗: Within 90 minutes from start of infusion
Conversion of AF to SR with maintenance of SR maintained for at least 1 minute
次要结局
- Wide QRS Tachycardias(From start of study drug infusion until discharge from hospital on study day 2.)
- Heart Rhythm. Number of Participants With Early Relapse Into AF.(Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR)
- Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion(During 24 hours following start of study drug infusion)
- Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.(During 13 to 18 days following study drug infusion)
- Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.(Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.)
- Maximal Observed Plasma Concentration of AZD1305(Up to 24 hours following start of study drug infusion)
- Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days(Conversion from AF to SR within 90 minutes from start of infusion)
- Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.(Conversion from AF to SR within 90 minutes from start of infusion)
- Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months(Conversion from AF to SR within 90 minutes from start of infusion)
- Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion(Six hours following start of study drug infusion)