StrokeNCT05086874
Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients
An observational study of Stroke and Cerebral Infarction, run by Xin Huang at 1 site in China.
Trial summary
This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Cerebral Infarction, Brain Infarction
- What is being tested?
- butylphthalide
- How many people
- 81,292 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to 1 Mar 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Doctors diagnosed with ischemic stroke patients
Who may be able to join
- From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization.
Who cannot join
- Patients who are unable to obtain information such as medical advice, laboratory test results, etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong Provincial, 250014
About this study
Official title: A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke
This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.
Read the detailed description
Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate.
Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world.
Therefore, it is planned to include 10,000 patients who used butylphthalide or Edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.
- Conditions
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases
- Being tested
- butylphthalide
- Keywords
- butylphthalide, Ischemic Strokes, Real world research
- Medical subject headings
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
butylphthalideOther
Also called observational only ,no intervention
Observational only and no predesigned interventions in this study
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | A group of patients with ischemic stroke, treated with butylphthalide Receives: Other: butylphthalide | |
| Non-exposed group | A group of patients with ischemic stroke, treated with Edaravone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
The probability of unanticipated and adverse medical events after the patient receives medication, but it does not necessarily have a causal relationship with the treatment
Measured: 90days
Secondary outcomes (2)
NIHSS
NIH stroke scale (NIHSS) to assess the degree of neurological deficit in stroke patients. The score ranges from 0 to 42 points, the higher the score, the more severe the nerve damage. Patients with a baseline assessment of> 16 points are likely to die, while those with a score of <6 are likely to recover well; for each additional point, the probability of a good prognosis is reduced by 17%
Measured: 90days
mRS
Modified Rankin scale (mRS) is an indicator of the efficacy of functional disability. The score ranges from 0 to 5 points, and the clinical score will be increased to 6 points to indicate death. The higher the score, the more disability the patient is.
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start7 May 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xin Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Huang, Qianfoshan Hospital
- Investigators
- Xin Huang, Study director, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086874
- Sponsor's protocol ID
- QFS-HX-2021-DBT-HGX-001
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Haven't decided yet
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05086874
- Acronym / sponsor ID
- QFS-HX-2021-DBT-HGX-001
- Conditions
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases
- Keywords
- butylphthalide, Ischemic Strokes, Real world research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,292 participants (actual)
- Lead sponsor
- Xin HuangUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 21 Oct 2021 (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.
This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.
Detailed description
Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate.
Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world.
Therefore, it is planned to include 10,000 patients who used butylphthalide or Edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: butylphthalideA group of patients with ischemic stroke, treated with butylphthalide |
| Non-exposed group | – | –A group of patients with ischemic stroke, treated with Edaravone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Doctors diagnosed with ischemic stroke patients
Key inclusion criteria (1 listed)
- From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization.
Key exclusion criteria (1 listed)
- Patients who are unable to obtain information such as medical advice, laboratory test results, etc.
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 |
|---|---|---|
| butylphthalideAlso: observational only ,no interventionObservational only and no predesigned interventions in this study | Other | Exposed group |
Primary outcome
The incidence of adverse events
Time frame: 90days
The probability of unanticipated and adverse medical events after the patient receives medication, but it does not necessarily have a causal relationship with the treatment
2 secondary outcomes
NIHSS
Time frame: 90days
mRS
Time frame: 90days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided. Haven't decided yet
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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.
Xin Huang study director
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebral Infarction, run by Xin Huang 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (time frame: 90days). 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 9 Apr 2024.