Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
1 other identifier
observational
2,000
1 country
1
Brief Summary
Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation. The information registration of the target population will be collected with the hospital HIS system or LIS system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
February 13, 2019
CompletedStudy Start
First participant enrolled
February 18, 2019
CompletedFirst Posted
Study publicly available on registry
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMarch 14, 2019
February 1, 2019
11 months
February 13, 2019
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
From the beginning of the administration to 48 hours after the end of the administration.
Secondary Outcomes (6)
Number of Participants with adverse events
From the beginning of the administration to 48 hours after the end of the administration.
Heart rate
3 days before the beginning of the administration to 48 hours after the end of the administration.
The survival rate
30 days after the end of administration.
Blood pressure
3 days before the beginning of the administration to 48 hours after the end of the administration.
Respiratory rate
3 days before the beginning of the administration to 48 hours after the end of the administration.
- +1 more secondary outcomes
Interventions
Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.
Eligibility Criteria
Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
You may qualify if:
- Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
- Patients who have received or are about to receive Nifekalant Hydrochloride for treatment according to the instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sichuan Baili Pharmaceutical Co., Ltd.lead
- Peking University First Hospitalcollaborator
- Beijing Hospitalcollaborator
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Huo
Peking University First Hospital
- PRINCIPAL INVESTIGATOR
Jing Zhou
Peking University First Hospital
- PRINCIPAL INVESTIGATOR
Min Yi Cui
Peking University First Hospital
- PRINCIPAL INVESTIGATOR
Xin Hu
Beijing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 25, 2019
Study Start
February 18, 2019
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
March 14, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share