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

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.

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

Study Overview

• Status: Unknown
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Drug: Nifekalant hydrochloride; Drug: Amiodarone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 756
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jing Xiong; Phone Number: +86-028-85320612; Email: xiongjing@bailipharm.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Shenyang Military Region General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nifekalant hydrochloride; Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.; Other Names: Nifekalant Hydrochloride for Injection
Active Comparator: 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).	Drug: Amiodarone; Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.; Other Names: Amiodarone hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of efficacy	Efficacy of drugs in each group within 24 hours after administration.	24 hours after administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficiency rate without adjusting the drug dose	number of patients who no longer relapse after using the drug / total number of patients in the group × 100%	24 hours after administration.
Number of electrical cardioversion used during the treatment	Number of electrical cardioversion	24 hours after administration.
The success rate of DC in patients with first invalid cardioversion in the two groups	Number of patients ewith valid DC after the first invalid DC / Total number of patients with first invalid DC in this group × 100%	24 hours after administration.
The average time from the start of administration to the last VT/VF no longer occurs	Patients who changed drugs will not be included statistics on this indicator.	24 hours after administration.
LVEF	Echocardiography	Before administration, and 24h to 72h after the start of administration.
Survival rate	Survival rate of the two groups of patients	30 days after administration.
Number of ventricular tachycardia/ventricular fibrillation episodes	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	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	The effective rate of the drug in each group within 72 hours after administration.	72 hours after administration.

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Ling Ya Han, Shenyang Military Region General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): January 30, 2020
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone; Nifekalant
• Other Study ID Numbers: NTFS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No