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Trial record 13 of 132 for:    "Paroxysmal Ventricular Fibrillation"

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

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ClinicalTrials.gov Identifier: NCT03855826
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sichuan Baili Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ventricular Fibrillation Drug: Nifekalant hydrochloride Drug: Amiodarone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020


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 Name: 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 Name: Amiodarone hydrochloride




Primary Outcome Measures :
  1. The rate of efficacy [ Time Frame: 24 hours after administration. ]
    Efficacy of drugs in each group within 24 hours after administration.


Secondary Outcome Measures :
  1. The efficiency rate without adjusting the drug dose [ Time Frame: 24 hours after administration. ]
    number of patients who no longer relapse after using the drug / total number of patients in the group × 100%

  2. Number of electrical cardioversion used during the treatment [ Time Frame: 24 hours after administration. ]
    Number of electrical cardioversion

  3. The success rate of DC in patients with first invalid cardioversion in the two groups [ Time Frame: 24 hours after administration. ]
    Number of patients ewith valid DC after the first invalid DC / Total number of patients with first invalid DC in this group × 100%

  4. The average time from the start of administration to the last VT/VF no longer occurs [ Time Frame: 24 hours after administration. ]
    Patients who changed drugs will not be included statistics on this indicator.

  5. LVEF [ Time Frame: Before administration, and 24h to 72h after the start of administration. ]
    Echocardiography

  6. Survival rate [ Time Frame: 30 days after administration. ]
    Survival rate of the two groups of patients

  7. Number of ventricular tachycardia/ventricular fibrillation episodes [ Time Frame: Within 72 hours after drug administration. ]
    Number of ventricular tachycardia/ventricular fibrillation episodes .

  8. 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. ]
    The number of patients who need to continue the intravenous research drug after 24 hours in the two groups

  9. The effective rate of the drug in each group within 72 hours after administration [ Time Frame: 72 hours after administration. ]
    The effective rate of the drug in each group within 72 hours after administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855826


Contacts
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Contact: Jing Xiong +86-028-85320612 xiongjing@bailipharm.com

Locations
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China, Liaoning
Shenyang Military Region General Hospital Recruiting
Shenyang, Liaoning, China
Sponsors and Collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Ling Ya Han Shenyang Military Region General Hospital

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Responsible Party: Sichuan Baili Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03855826     History of Changes
Other Study ID Numbers: NTFS01
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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