A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 217
- 主要终点
- Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.
详细描述
Participants received a 10-minute intravenous (IV) infusion of vernakalant (3 mg/kg) or an equivalent amount of normal saline (placebo), followed by a 15-minute observation period. If the participant was still in atrial fibrillation or atrial flutter, a second 10-minute IV infusion of vernakalant (2 mg/kg) or an equivalent amount of placebo was administered unless the participant experienced any dose-stopping criteria after the start of the first infusion. If a participant converted to sinus rhythm during the first or second infusion, that infusion was completed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be not pregnant or nursing and if pre-menopausal, must be using an effective form of birth control from time of screening until 30 days post study treatment
- •Subject must have recent onset (> 3 hours to <= 7 days) symptomatic AF to be best managed by acute conversion to SR
- •Subject must have adequate anticoagulant therapy
- •Subject must have systolic blood pressure (SBP) above 90 mmHg and less than 160 mmHg and diastolic blood pressure (DBP) less than 95 mmHg at screening and baseline
- •Subject must have a body weight between 45 and 136 kg, inclusive (99 and 300 lbs)
排除标准
- •Subject has a history of heart failure or documentation of left ventricular dysfunction
- •Subject has known or suspected prolonged QT or uncorrected QT interval of > 0.440 sec
- •Subject has symptomatic bradycardia or ventricular rate less than 50 bpm at Screening, unless controlled by a pacemaker
- •Subject has bradycardia (heart rate less than 50 bpm) or hypotension (SBP less that 90 mmHg) after receiving a loading, bolus dose, or sustained infusion of any rate control medication during Screening
- •Subject has a QRS interval > 0.14 sec., unless subject has a pacemaker
- •Subject had a myocardial infarction (MI), acute coronary syndrome, cardiac surgery (including percutaneous transluminal coronary angioplasty (PTCA) or stent placement), within 30 days prior to enrollment or subject has evidence of new ischemic changes on Screening 12-lead ECG
- •Subject has troponin I or T levels beyond the upper limit of normal for the local lab
- •Subject has significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
- •Subject has failed electrical cardioversion for AF at anytime
- •Subject has failed pharmacologic conversion with an intravenous Class I or Class III antiarrhythmic drug for this episode of AF
- •Subject has any known reversible causes of AF such as alcohol intoxication, pulmonary embolism, hyperthyroidism, acute pericarditis or hypoxemia
- •Subject has uncorrected electrolyte imbalance
- •Subject has clinical evidence of digoxin toxicity
- •Subject has a history of clinically significant illness (e.g. neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, endocrine, hematological, or psychiatric), medical condition or laboratory abnormality within 4 weeks prior to Screening
研究组 & 干预措施
Vernakalant
Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes
干预措施: Vernakalant (Drug)
Placebo
Placebo (saline) administered IV at same volume and rate as per dosing schedule for vernakalant
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death
时间窗: Occurring within the first two hours after start of study treatment
Hypotension defined as: systolic blood pressure (SBP) \<90 mmHg and treated with pressors; SBP \<90 mmHg and treated with albumin, dextran or hydroxyethyl starch; or SBP \<90 mmHg and seizures. Ventricular arrhythmias defined as: Sustained ventricular tachycardia with a heart rate of \>120 beats per minute. Sustained tachycardia defined as lasting \>30 seconds; Torsade de Pointes with a duration of \>10 seconds; Ventricular fibrillation of any duration.
Number of Participant with Successful Conversion to Sinus rhythm (SR)
时间窗: Occurring within 90 minutes of first exposure to study treatment
Successful conversion defined as return to sinus rhythm for at least 1 minute documented by Holter electrocardiogram (ECG) or by two consecutive 12-lead ECGs recorded \> 1 minute apart within 90 minutes of first exposure to study treatment
次要结局
- Time from First Exposure to Study Treatment to Conversion of AF to SR(Occurring within 90 minutes after study treatment)
- Number of Participants who Report No Symptoms(Occurring 90 minutes after first exposure to study treatment)