Acute Ischemic StrokePhase 3BASTNCT03539445
Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment
A Phase 3 study testing Butylphthalide in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Butylphthalide, as a well-known neuroprotective medication, is a family of compounds initially isolated from the seeds of Apium graveolens Linn, of which active ingredient is dl-3-N-butylphthalide (dl-NBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Butylphthalide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,216 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Jul 2022
- Phase
- Phase 3
- 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
- Female or male aged ≥ 18 years.
- Acute ischemic stroke.
- Within 6 hours from symptom onset.
- Baseline NIHSS range 4 from 25.
- Proceed to iv-rtPA or intravascular therapy including arterial thrombolysis and mechanical thrombectomy or bridging therapy.
- Provision of informed consent.
Who cannot join
- Modified Rankin Scale（mRS）>1 at randomization (pre-morbid historical assessment).
- ASPECT ≤ 6 confirmed by the pre-operation CT scan.
- Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
- Use any drugs related to Butylphthalide during onset between randomization.
- Dysphagia at the onset of stroke.
- History of coagulation dysfunction, systemic bleeding, neutropenia or thrombocytopenia.
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- History of chronic hepatopathy, liver and kidney dysfunction, elevating Alanine transaminase (> 3 times normal upper limit), elevating serum creatinine (> 2 times normal upper limit).
- History of severe cardio-pulmonary diseases which is not suitable for this study judged by investigator.
- History of bradycardia (heart rate < 60 beats/m) and Sick sinus syndrome.
- Severe non-cardiovascular comorbidity with life expectancy < 3 months or failed to follow the study for other reasons.
- History of drug or food allergy, or are known to be allergic to the drug components of this study.
- Contraindications for the digital subtraction angiography procedure, including severe allergy for contrast agent with or without Iodine.
- Pregnancy or lactation, and women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test.
- Incapable to follow this study for mental illness, cognitive or emotional disorder.
- Unsuitable for this study in the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment: A Prospective, Randomized, Double-blinded, Placebo Parallel Controlled, Multiple-center Trial.
Butylphthalide, as a well-known neuroprotective medication, is a family of compounds initially isolated from the seeds of Apium graveolens Linn, of which active ingredient is dl-3-N-butylphthalide (dl-NBP). With the significant effects of reducing the cerebral ischemic damage and eventually improving patients' clinical outcomes, by the potential mechanisms of promoting microcirculation, as well as releasing oxidative stress, mitochondrial dysfunction and poststroke inflammation, dl-NBP has been widely applied in acute ischemic stroke as an anti-ischemic drug in China since 2002. While with the evolution of using iv. recombinant tissue plasminogen activator（rtPA ）and mechanical thrombectomy in acute ischemic stroke（AIS）patients, it is still undefined whether combination therapy with dl-NBP could enhance the curative effect. The primary purpose of this trial is to evaluate the recovery of neurological deficits in AIS patients who receive iv-rtPA and/or mechanical thrombectomy with the a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy versus a 3-month regimen of Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and followed by Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy.
Read the detailed description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 1200 patients (Age≥18years) within 6 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 4-25 points and intend to be treated with iv-rtPA and/or mechanical thrombectomy will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content, meanwhile the first injection will be within 6 hours from stroke onset : 1) one group will receive Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days, then take Butylphthalide Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy; 2) the other group will receive Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and then take Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy. The primary objective is to explore whether the dl-NBP can improve the proportion of patients with a favorable outcome after receiving iv-rtPA and/or mechanical thrombectomy. The study consists of four visits including the day of randomization, 2 days after the first injection, 14 days when the injection therapy is done, and 30, 60 and 90 days when the oral therapy is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The favorable outcome based on the 90-day modified Rankin Scale score was adjusted for baseline stroke severity, which was defined as a modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25. The trial is anticipated to last from June 2018 to December 2022 with 1200 subjects recruited form 36 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Butylphthalide, Butylphthalide Placebo
- Keywords
- AIS, butylphthalide, mechanical thrombectomy, iv-rtPA, recovery of dysfunction
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButylphthalideDrug
Also called dl-NBP
This group will receive a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90.
Butylphthalide PlaceboDrug
Also called Blank
This group will receive a 3-month regimen of Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90.
| Study group | Role | What they receive |
|---|---|---|
| Butylphthalide | Experimental | Drug: Butylphthalide Sodium Chloride Injection and Butylphthalide Soft Capsules Receives: Drug: Butylphthalide |
| Placebos | Placebo comparator | Drug: Butylphthalide Placebo Injection and Butylphthalide Placebo Soft Capsules Receives: Drug: Butylphthalide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable outcome
A modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25.
Measured: 90 days
Secondary outcomes (19)
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline
Measured: 90 days
Cerebral infarction volume
Cerebral infarction volume at the Day 14 of the therapy
Measured: 14 days
Recanalization rate
Recanalization rate at the first 24 hours during the therapy
Measured: 24 hours
Symptomatic intracranial hemorrhage
The percentage of symptomatic intracranial hemorrhage.
Measured: 24 hours
Recurrent stroke
New symptomatic vascular events (ischemic or hemorrhage) .
Measured: 90 days
Recurrent ischemic stroke
Recurrent symptomatic ischemic stroke events
Measured: 90 days
Any vascular complications
The quantity of patients who has complications with vascular events (recurrent symptomatic ischemic stroke, myocardiac infarction, vascular death)
Measured: 90 days
EuroQol-5-Dimensions Scale（EQ-5D）questionnaire for measuring generic health status
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy，which consists of two components：EuroQol-5-Dimensions Scale（EQ-5D）for health state description and Visual analogue scale（VAS）for self-evaluation. EQ-5D descriptive system covers five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels (no problem, some problems, and severe problems). The EQ-5D descriptive system generates 243 health states, each of which was assigned a utility score ranging from -0.59 to 1.00 (full health). While the EQ-5D also includes a 20-cm vertical VAS, with 0 and 100 representing worst and best imaginable health states, respectively. We classified the EQ-VAS scores into four groups, namely<65 (bad), 65 to 79 (fair), 80 to 89 (good), and 90 to 100 (excellent).
Measured: 90 days
Cognitive function evaluated by the Mini-mental State Examination（MMSE）
Cognitive function evaluated by the Mini-mental State Examination（MMSE）at the end of the treatment，which effected by age and education experience. Cognitive impairment is diagnosed when MMSE ≤17 for illiteracy，MMSE ≤20 for those who take less than 6-years primary education，MMSE ≤24 for those have at least a middle school education.
Measured: 90 days
Cognitive function evaluated by the Montreal Cognitive Assessment（MoCA）
Cognitive function evaluated by the Montreal Cognitive Assessment（MoCA） Scales at the end of the treatment, while taking MoCA <26 as cognitive impairment. Further more, when patient has a education experiment less than 12 years, investigator should give him or her one more score.
Measured: 90 days
Favorable outcome
A modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25.
Measured: 14 days
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline
Measured: 14 days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Measured: 90 days
Symptomatic intracranial hemorrhage
The percentage of symptomatic intracranial hemorrhage.
Measured: 90 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Measured: 90 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Measured: 90 days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Measured: 14 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Measured: 14 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jul 2018
- Primary completion22 May 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539445
- Sponsor's protocol ID
- 2016YFC1301501
- Acronym
- BAST
- Status last verified
- Aug 2022
- First submitted
- 9 Apr 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Q, Tian X, Xia X, Xu Q, Gao M, Zhang L, Wang A. Favorable Systemic Immune-Inflammation Status Enhances the Neuroprotective Effects of Butylphthalide in Ischemic Stroke: A Post Hoc Analysis of BAST Trial. CNS Neurosci Ther. 2026 Jun;32(6):e70989. doi: 10.1002/cns.70989.
PubMed 42329209Wang A, Jia B, Zhang X, Huo X, Chen J, Gui L, Cai Y, Guo Z, Han Y, Peng Z, Jing P, Chen Y, Liu Y, Yang Y, Wang F, Sun Z, Li T, Sun H, Yuan H, Shao H, Gao L, Zhang P, Wang F, Cao X, Shi W, Li C, Yang J, Zhang H, Wang F, Deng J, Liu Y, Deng W, Song C, Chen H, He L, Zhao H, Li X, Yang H, Zhou Z, Wang Y, Miao Z; BAST Investigators. Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Aug 1;80(8):851-859. doi: 10.1001/jamaneurol.2023.1871.
PubMed 37358859Zhang X, Wang A, Zhang JY, Jia B, Huo X, Zuo Y, Tian X, Wang Y, Miao Z; BAST study investigators. Efficacy and safety of butylphthalide for patients who had acute ischaemic stroke receiving intravenous thrombolysis or endovascular treatment (BAST trial): study protocol for a randomised placebo-controlled trial. BMJ Open. 2021 May 25;11(5):e045559. doi: 10.1136/bmjopen-2020-045559.
PubMed 34035100
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment: A Prospective, Randomized, Double-blinded, Placebo Parallel Controlled, Multiple-center Trial.
- ClinicalTrials.gov ID
- NCT03539445
- Acronym / sponsor ID
- BAST / 2016YFC1301501
- Conditions
- Acute Ischemic Stroke
- Keywords
- AIS, butylphthalide, mechanical thrombectomy, iv-rtPA, recovery of dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 29 May 2018 (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.
Butylphthalide, as a well-known neuroprotective medication, is a family of compounds initially isolated from the seeds of Apium graveolens Linn, of which active ingredient is dl-3-N-butylphthalide (dl-NBP). With the significant effects of reducing the cerebral ischemic damage and eventually improving patients' clinical outcomes, by the potential mechanisms of promoting microcirculation, as well as releasing oxidative stress, mitochondrial dysfunction and poststroke inflammation, dl-NBP has been widely applied in acute ischemic stroke as an anti-ischemic drug in China since 2002. While with the evolution of using iv. recombinant tissue plasminogen activator（rtPA ）and mechanical thrombectomy in acute ischemic stroke（AIS）patients, it is still undefined whether combination therapy with dl-NBP could enhance the curative effect. The primary purpose of this trial is to evaluate the recovery of neurological deficits in AIS patients who receive iv-rtPA and/or mechanical thrombectomy with the a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy versus a 3-month regimen of Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and followed by Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy.
Detailed description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 1200 patients (Age≥18years) within 6 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 4-25 points and intend to be treated with iv-rtPA and/or mechanical thrombectomy will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content, meanwhile the first injection will be within 6 hours from stroke onset : 1) one group will receive Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days, then take Butylphthalide Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy; 2) the other group will receive Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and then take Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy. The primary objective is to explore whether the dl-NBP can improve the proportion of patients with a favorable outcome after receiving iv-rtPA and/or mechanical thrombectomy. The study consists of four visits including the day of randomization, 2 days after the first injection, 14 days when the injection therapy is done, and 30, 60 and 90 days when the oral therapy is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The favorable outcome based on the 90-day modified Rankin Scale score was adjusted for baseline stroke severity, which was defined as a modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25. The trial is anticipated to last from June 2018 to December 2022 with 1200 subjects recruited form 36 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butylphthalide | Experimental | Drug: ButylphthalideDrug: Butylphthalide Sodium Chloride Injection and Butylphthalide Soft Capsules |
| Placebos | Placebo comparator | Drug: Butylphthalide PlaceboDrug: Butylphthalide Placebo Injection and Butylphthalide Placebo Soft Capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male aged ≥ 18 years.
- Acute ischemic stroke.
- Within 6 hours from symptom onset.
- Baseline NIHSS range 4 from 25.
- Proceed to iv-rtPA or intravascular therapy including arterial thrombolysis and mechanical thrombectomy or bridging therapy.
Key exclusion criteria (15 listed)
- Modified Rankin Scale（mRS）>1 at randomization (pre-morbid historical assessment).
- ASPECT ≤ 6 confirmed by the pre-operation CT scan.
- Diagnosis of intracranial hemorrhagic disease, such as intracranial hemorrhage, subarachnoid hemorrhage and so on.
- Use any drugs related to Butylphthalide during onset between randomization.
- Dysphagia at the onset of stroke.
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: dl-NBPThis group will receive a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90. | Drug | Butylphthalide |
| Butylphthalide PlaceboAlso: BlankThis group will receive a 3-month regimen of Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90. | Drug | Placebos |
Primary outcome
Favorable outcome
Time frame: 90 days
A modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25.
19 secondary outcomes
Neurological recovery
Time frame: 90 days
Cerebral infarction volume
Time frame: 14 days
Recanalization rate
Time frame: 24 hours
Symptomatic intracranial hemorrhage
Time frame: 24 hours
Recurrent stroke
Time frame: 90 days
Recurrent ischemic stroke
Time frame: 90 days
Any vascular complications
Time frame: 90 days
EuroQol-5-Dimensions Scale（EQ-5D）questionnaire for measuring generic health status
Time frame: 90 days
Cognitive function evaluated by the Mini-mental State Examination（MMSE）
Time frame: 90 days
Cognitive function evaluated by the Montreal Cognitive Assessment（MoCA）
Time frame: 90 days
Favorable outcome
Time frame: 14 days
Neurological recovery
Time frame: 14 days
Severity Adverse Event
Time frame: 90 days
Symptomatic intracranial hemorrhage
Time frame: 90 days
Total mortality
Time frame: 90 days
Adverse Events
Time frame: 90 days
Severity Adverse Event
Time frame: 14 days
Total mortality
Time frame: 14 days
Adverse Events
Time frame: 14 days
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 5 Aug 2022.
- Derived from this study: PubMed 42329209Zhou Q, Tian X, Xia X, Xu Q, Gao M, Zhang L, Wang A. Favorable Systemic Immune-Inflammation Status Enhances the Neuroprotective Effects of Butylphthalide in Ischemic Stroke: A Post Hoc Analysis of BAST Trial. CNS Neurosci Ther. 2026 Jun;32(6):e70989. doi: 10.1002/cns.70989.
- Derived from this study: PubMed 37358859Wang A, Jia B, Zhang X, Huo X, Chen J, Gui L, Cai Y, Guo Z, Han Y, Peng Z, Jing P, Chen Y, Liu Y, Yang Y, Wang F, Sun Z, Li T, Sun H, Yuan H, Shao H, Gao L, Zhang P, Wang F, Cao X, Shi W, Li C, Yang J, Zhang H, Wang F, Deng J, Liu Y, Deng W, Song C, Chen H, He L, Zhao H, Li X, Yang H, Zhou Z, Wang Y, Miao Z; BAST Investigators. Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Aug 1;80(8):851-859. doi: 10.1001/jamaneurol.2023.1871.
- Derived from this study: PubMed 34035100Zhang X, Wang A, Zhang JY, Jia B, Huo X, Zuo Y, Tian X, Wang Y, Miao Z; BAST study investigators. Efficacy and safety of butylphthalide for patients who had acute ischaemic stroke receiving intravenous thrombolysis or endovascular treatment (BAST trial): study protocol for a randomised placebo-controlled trial. BMJ Open. 2021 May 25;11(5):e045559. doi: 10.1136/bmjopen-2020-045559.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Butylphthalide in people with Acute Ischemic Stroke, run by Beijing Tiantan 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 6 inclusion and 15 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 5 Aug 2022. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Favorable outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539445, which also lists 3 linked publications.
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 5 Aug 2022.