Clinical trial NCT03855826: Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The rate of efficacy
timeFrame: 24 hours after administration.
Secondary outcomes:
measure: The efficiency rate without adjusting the drug dose
timeFrame: 24 hours after administration.
measure: Number of electrical cardioversion used during the treatment
timeFrame: 24 hours after administration.
measure: The success rate of DC in patients with first invalid cardioversion in the two groups
timeFrame: 24 hours after administration.
measure: The average time from the start of administration to the last VT/VF no longer occurs
timeFrame: 24 hours after administration.
measure: LVEF
timeFrame: Before administration, and 24h to 72h after the start of administration.
measure: Survival rate
timeFrame: 30 days after administration.
measure: Number of ventricular tachycardia/ventricular fibrillation episodes
timeFrame: Within 72 hours after drug administration.
measure: The number of patients who need to continue the intravenous research drug after 24 hours in the two groups
timeFrame: 24 hours after the start of the adminstration.
measure: The effective rate of the drug in each group within 72 hours after administration
timeFrame: 72 hours after administration.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenyang Military Region General Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Military Region General Hospital
name: Ling Ya Han
role: PRINCIPAL_INVESTIGATOR
References: