Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection in the Treatment of Ventricular Tachycardia and Ventricular Fibrillation. A Multicenter, Randomized, Controlled, Open-label, Clinical Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- The rate of efficacy
研究概览
简要总结
Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.
详细描述
After patients are hospitalized, they will be treated as usual in addition to antiarrhythmic drugs. DC will be performed again according to normal procedures for patients who were ineffective. Arrhythmia drugs can only be used with nifekalant or amiodarone at random.
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
- •Patients with persistent ventricular tachycardia or ventricular fibrillation who have a combined physical heart disease, or who have a conventional drug ineffective or persistent idiopathic ventricular tachycardia with amiodarone indications;
- •Age ≥ 18 years old, gender is not limited.
排除标准
- •Patients with prolonged ventricular tachycardia with QT interval and patients with QTc interval of more than 500 ms before administration;
- •Patients with torsades de pointes (Tdp);
- •Patients with Brugada syndrome;
- •Patients with severe atrioventricular block and without pacing protection;
- •Patients with hypertrophic cardiomyopathy (HCM) with ventricular septal thickness or (and) left ventricular wall ≥ 15 mm;
- •Pregnant or lactating women;
- •Patients who are not suitable for the study, considered by investigators.
研究组 & 干预措施
Nifekalant Hydrochloride
Nifekalant hydrochloride (50mg) should be dissolved into a 50ml dilution solution (0.9% sodium chloride injection or 5% glucose injection), and configured as 1mg/ml solution of nificaine hydrochloride. The dosage should be taken as needed. The diluted solution should be used within 24 hours. The amount of fluid per hour should not exceed 50ml when intravenously infused. It is recommended to use intravenous pump.
干预措施: Nifekalant hydrochloride (Drug)
Amiodarone
The concentration of more than 2 ampoule amiodarone injection in 500 ml (only isotonic grape solution) is suitable. Amiodarone should be administered as far as possible via the central venous route (administered separately).
干预措施: Amiodarone (Drug)
结局指标
主要结局
The rate of efficacy
时间窗: 24 hours after administration.
Efficacy of drugs in each group within 24 hours after administration.
次要结局
- LVEF(Before administration, and 24h to 72h after the start of administration.)
- The average time from the start of administration to the last VT/VF no longer occurs(24 hours after administration.)
- The efficiency rate without adjusting the drug dose(24 hours after administration.)
- The success rate of DC in patients with first invalid cardioversion in the two groups(24 hours after administration.)
- Number of electrical cardioversion used during the treatment(24 hours after administration.)
- Survival rate(30 days after administration.)
- Number of ventricular tachycardia/ventricular fibrillation episodes(Within 72 hours after drug administration.)
- The number of patients who need to continue the intravenous research drug after 24 hours in the two groups(24 hours after the start of the adminstration.)
- The effective rate of the drug in each group within 72 hours after administration(72 hours after administration.)