Ventricular TachycardiaPhase 4NCT03855826
Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
A Phase 4 study testing Nifekalant hydrochloride and Amiodarone in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Nifekalant hydrochloride and Amiodarone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2019to 30 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenyang Military Region General Hospital
Shenyang, Liaoning
About this study
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.
Efficacy and safety evaluation of amiodarone and Nifekalant hydrochloride(NIF) for the treatment of ventricular tachycardia and ventricular fibrillation.
Read the 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.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Nifekalant hydrochloride, Amiodarone
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifekalant hydrochlorideDrug
Also called Nifekalant Hydrochloride for Injection
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.
AmiodaroneDrug
Also called Amiodarone 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of efficacy
Efficacy of drugs in each group within 24 hours after administration.
Measured: 24 hours after administration.
Secondary outcomes (9)
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%
Measured: 24 hours after administration.
Number of electrical cardioversion used during the treatment
Number of electrical cardioversion
Measured: 24 hours after administration.
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%
Measured: 24 hours after administration.
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.
Measured: 24 hours after administration.
LVEF
Echocardiography
Measured: Before administration, and 24h to 72h after the start of administration.
Survival rate
Survival rate of the two groups of patients
Measured: 30 days after administration.
Number of ventricular tachycardia/ventricular fibrillation episodes
Number of ventricular tachycardia/ventricular fibrillation episodes .
Measured: Within 72 hours after drug administration.
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
Measured: 24 hours after the start of the adminstration.
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.
Measured: 72 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start15 Jan 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ling Ya Han, Principal investigator, Shenyang Military Region General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855826
- Sponsor's protocol ID
- NTFS01
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03855826
- Acronym / sponsor ID
- NTFS01
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifekalant Hydrochloride | Experimental | Drug: Nifekalant hydrochlorideNifekalant 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. |
| Amiodarone | Active comparator | Drug: AmiodaroneThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifekalant hydrochlorideAlso: Nifekalant Hydrochloride for InjectionBoth 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. | Drug | Nifekalant Hydrochloride |
| AmiodaroneAlso: Amiodarone hydrochlorideBoth 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. | Drug | Amiodarone |
Primary outcome
The rate of efficacy
Time frame: 24 hours after administration.
Efficacy of drugs in each group within 24 hours after administration.
9 secondary outcomes
The efficiency rate without adjusting the drug dose
Time frame: 24 hours after administration.
Number of electrical cardioversion used during the treatment
Time frame: 24 hours after administration.
The success rate of DC in patients with first invalid cardioversion in the two groups
Time frame: 24 hours after administration.
The average time from the start of administration to the last VT/VF no longer occurs
Time frame: 24 hours after administration.
LVEF
Time frame: Before administration, and 24h to 72h after the start of administration.
Survival rate
Time frame: 30 days after administration.
Number of ventricular tachycardia/ventricular fibrillation episodes
Time frame: Within 72 hours after drug administration.
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 effective rate of the drug in each group within 72 hours after administration
Time frame: 72 hours after administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Ya Han principal investigator
Shenyang Military Region General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifekalant hydrochloride and Amiodarone in people with Ventricular Tachycardia and Ventricular Fibrillation, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Xiong (+86-028-85320612, xiongjing@bailipharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of efficacy (time frame: 24 hours after administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.