Back to resultsEvaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
Primary Purpose
Ventricular Tachycardia, Ventricular Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nifekalant hydrochloride
Amiodarone
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
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.
Sites / Locations
- Shenyang Military Region General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nifekalant Hydrochloride
Amiodarone
Arm 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.
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).
Outcomes
Primary Outcome Measures
The rate of efficacy
Efficacy of drugs in each group within 24 hours after administration.
Secondary Outcome Measures
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%
Number of electrical cardioversion used during the treatment
Number of electrical cardioversion
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%
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.
LVEF
Echocardiography
Survival rate
Survival rate of the two groups of patients
Number of ventricular tachycardia/ventricular fibrillation episodes
Number of ventricular tachycardia/ventricular fibrillation episodes .
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
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.
Full Information
NCT ID
NCT03855826
First Posted
February 25, 2019
Last Updated
February 25, 2019
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03855826
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
756 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nifekalant Hydrochloride
Arm Type
Experimental
Arm 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.
Arm Title
Amiodarone
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Nifekalant hydrochloride
Other Intervention Name(s)
Nifekalant Hydrochloride for Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Other Intervention Name(s)
Amiodarone hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of efficacy
Description
Efficacy of drugs in each group within 24 hours after administration.
Time Frame
24 hours after administration.
Secondary Outcome Measure Information:
Title
The efficiency rate without adjusting the drug dose
Description
number of patients who no longer relapse after using the drug / total number of patients in the group × 100%
Time Frame
24 hours after administration.
Title
Number of electrical cardioversion used during the treatment
Description
Number of electrical cardioversion
Time Frame
24 hours after administration.
Title
The success rate of DC in patients with first invalid cardioversion in the two groups
Description
Number of patients ewith valid DC after the first invalid DC / Total number of patients with first invalid DC in this group × 100%
Time Frame
24 hours after administration.
Title
The average time from the start of administration to the last VT/VF no longer occurs
Description
Patients who changed drugs will not be included statistics on this indicator.
Time Frame
24 hours after administration.
Title
LVEF
Description
Echocardiography
Time Frame
Before administration, and 24h to 72h after the start of administration.
Title
Survival rate
Description
Survival rate of the two groups of patients
Time Frame
30 days after administration.
Title
Number of ventricular tachycardia/ventricular fibrillation episodes
Description
Number of ventricular tachycardia/ventricular fibrillation episodes .
Time Frame
Within 72 hours after drug administration.
Title
The number of patients who need to continue the intravenous research drug after 24 hours in the two groups
Description
The number of patients who need to continue the intravenous research drug after 24 hours in the two groups
Time Frame
24 hours after the start of the adminstration.
Title
The effective rate of the drug in each group within 72 hours after administration
Description
The effective rate of the drug in each group within 72 hours after administration.
Time Frame
72 hours after administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Xiong
Phone
+86-028-85320612
Email
xiongjing@bailipharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Ya Han
Organizational Affiliation
Shenyang Military Region General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenyang Military Region General Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
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