StrokePhase 4NCT05068349
For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.
A Phase 4 study testing Butylphthalide in people with Stroke and Cerebral Infarction, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Infarction, Brain Infarction
- What is being tested?
- Butylphthalide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to Dec 2025
- 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
- 1. Female or male aged ≥ 18 years.
- 2. Acute ischemic stroke within 48 hours of onset
- 3. Examination to exclude intracranial hemorrhage
- 4. Provision of informed consent.
Who cannot join
- 1.Head CT or MRI suggests the presence of intracranial hemorrhagic disease
- 2.Patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute
- 3.Abnormal liver function (transaminase ALT or AST exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc
- 4.Allergy to Butylphthalide
Trial locations and contacts
1 site in 1 country.
Shuxian Lv contact
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong Provincial
Xin Huang, 13791120711@126.com
Xueyan Cui, qfscxy@126.com
About this study
Official title: A Real-world Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.
This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.
Read the detailed description
Ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. Patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life.
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 the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions.
Thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. The patients will be collected for experiment before and after treatment. Laboratory data, electrocardiogram, NIHSS, mRS, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. In addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.
- Conditions
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases
- Being tested
- Butylphthalide
- Keywords
- Butylphthalide, Ischemic Strokes
- Medical subject headings
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases, Vascular Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButylphthalideDrug
Also called 3-n-Butylphthalide
Butylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days.
| Study group | Role | What they receive |
|---|---|---|
| A group of patients with ischemic stroke were treated with butylphthalide injection and capsules | Experimental | Patients eligible for inclusion and exclusion are only divided into one group, no controls or other. Receives: Drug: Butylphthalide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events caused by treatment
In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.
Measured: 90 days
Secondary outcomes (3)
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: 90 days
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: 90 days
Correlation between blood drug concentration and adverse events
Try to find the relationship between pharmacokinetic parameters and adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start7 May 2022
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- More trials run by Qianfoshan HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group clinical trial is a study with only one group, and no corresponding control group is designed for the experimental group.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Huang, Qianfoshan Hospital
- Investigators
- Xin Huang, Study director, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068349
- Sponsor's protocol ID
- QFS-HX-2021-DBT-001
- Status last verified
- Apr 2024
- First submitted
- 20 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
- Yes
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 Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT05068349
- Acronym / sponsor ID
- QFS-HX-2021-DBT-001
- Conditions
- Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Nervous System Diseases, Central Nervous System Diseases
- Keywords
- Butylphthalide, Ischemic Strokes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 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 prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.
Detailed description
Ischemic stroke is one of the diseases that seriously threaten human health, with the characteristics of high incidence, high disability and high recurrence rate. Patients will not only suffer from impaired physical function, but also mental symptoms, social function and other obstacles, which seriously affect the quality of life.
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 the treatment of ischemic stroke with butylphthalide, there is still a lack of big data research based on real-world efficacy and safety; there is a lack of data on the pharmacokinetics of elderly patients and their correlation with adverse reactions.
Thus, it is estimated that 300 patients will be enrolled and given intravenous butylphthalide sodium chloride injection 25mg twice a day for 7-14 days, and then oral butylphthalide soft capsule 0.2g three times a day for 76-83 days. The patients will be collected for experiment before and after treatment. Laboratory data, electrocardiogram, NIHSS, mRS, combined medication and adverse events, etc., to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke. In addition, a population pharmacokinetic model of butylphthalide in elderly patients was established for 50 of them.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group clinical trial is a study with only one group, and no corresponding control group is designed for the experimental group.
| Arm | Type | Receives |
|---|---|---|
| A group of patients with ischemic stroke were treated with butylphthalide injection and capsules | Experimental | Drug: ButylphthalidePatients eligible for inclusion and exclusion are only divided into one group, no controls or other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Female or male aged ≥ 18 years.
- 2. Acute ischemic stroke within 48 hours of onset
- 3. Examination to exclude intracranial hemorrhage
- 4. Provision of informed consent.
Key exclusion criteria (4 listed)
- 1.Head CT or MRI suggests the presence of intracranial hemorrhagic disease
- 2.Patients with cerebral embolism or suspected cerebral embolism with severe atrioventricular block disease, atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate less than 50 beats per minute
- 3.Abnormal liver function (transaminase ALT or AST exceeding the upper limit of normal), abnormal renal function (creatinine exceeding the upper limit of normal), or suffering from other serious systemic diseases, etc
- 4.Allergy to Butylphthalide
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: 3-n-ButylphthalideButylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days. | Drug | A group of patients with ischemic stroke were treated with butylphthalide injection and capsules |
Primary outcome
The incidence of adverse events caused by treatment
Time frame: 90 days
In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.
3 secondary outcomes
NIHSS
Time frame: 90 days
mRS
Time frame: 90 days
Correlation between blood drug concentration and adverse events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Yes
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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.
Shuxian Lv contact
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?
A Phase 4 study testing Butylphthalide in people with Stroke and Cerebral Infarction, run by Qianfoshan Hospital 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 4 inclusion and 4 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 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.
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 Xueyan Cui (15053180972, qfscxy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events caused by treatment (time frame: 90 days). 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.