Status:
UNKNOWN
Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. Arrhyth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2020
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT03855826
Start Date
January 15 2019
End Date
January 30 2020
Last Update
February 27 2019
Active Locations (1)
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1
Shenyang Military Region General Hospital
Shenyang, Liaoning, China