NCT03855826

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
756

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 25, 2019

Last Update Submit

February 25, 2019

Conditions

Ventricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • The rate of efficacy

    Efficacy of drugs in each group within 24 hours after administration.

    24 hours after administration.

Secondary Outcomes (9)

  • The efficiency rate without adjusting the drug dose

    24 hours after administration.

  • Number of electrical cardioversion used during the treatment

    24 hours after administration.

  • The success rate of DC in patients with first invalid cardioversion in the two groups

    24 hours after administration.

  • The average time from the start of administration to the last VT/VF no longer occurs

    24 hours after administration.

  • LVEF

    Before administration, and 24h to 72h after the start of administration.

  • +4 more secondary outcomes

Study Arms (2)

Nifekalant Hydrochloride

EXPERIMENTAL

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

Amiodarone

ACTIVE COMPARATOR

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

Interventions

Nifekalant hydrochlorideDRUG

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.

Also known as: Nifekalant Hydrochloride for Injection
Nifekalant Hydrochloride
AmiodaroneDRUG

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.

Also known as: Amiodarone hydrochloride
Amiodarone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenyang Military Region General Hospital

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Interventions

nifekalantInjectionsAmiodarone

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ling Ya Han

    Shenyang Military Region General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Xiong

CONTACT

+86-028-85320612xiongjing@bailipharm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

January 15, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

CN(1)