Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.

Sichuan Baili Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Drug: Amiodarone; Drug: Nifekalant hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03855826

NTFS01

Details and patient eligibility

About

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

Full 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.

Enrollment: 756 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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756 participants in 2 patient groups

Nifekalant Hydrochloride

Experimental group

Description:

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.

Treatment:

Drug: Nifekalant hydrochloride

Amiodarone

Active Comparator group

Description:

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).

Treatment:

Drug: Amiodarone