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

Ventricular Tachycardia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855826
• Other study ID #: NTFS01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2019
• Source: Sichuan Baili Pharmaceutical Co., Ltd.
• Contact: Jing Xiong
• Phone: +86-028-85320612
• Email: xiongjing[@]bailipharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 756
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shenyang Military Region General Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Baili Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of efficacy	Efficacy of drugs in each group within 24 hours after administration.	24 hours after administration.
Secondary	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.
Secondary	Number of electrical cardioversion used during the treatment	Number of electrical cardioversion	24 hours after administration.
Secondary	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.
Secondary	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.
Secondary	LVEF	Echocardiography	Before administration, and 24h to 72h after the start of administration.
Secondary	Survival rate	Survival rate of the two groups of patients	30 days after administration.
Secondary	Number of ventricular tachycardia/ventricular fibrillation episodes	Number of ventricular tachycardia/ventricular fibrillation episodes .	Within 72 hours after drug administration.
Secondary	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.
Secondary	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.