Ischemic Stroke, AcuteSICASNCT06331494
Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery
A study testing Butylphthalide in people with Ischemic Stroke, Acute and Intracranial Atherosclerosis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Ischemic Stroke, Acute, Intracranial Atherosclerosis
- 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
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 31 Aug 2026
- Phase
- Interventional
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged 55-75 years;
- At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking;
- Symptomatic atherosclerotic stenosis in middle cerebral artery: large artery atherosclerotic cerebral infarction or TIA within 7 days of onset; 70%-99% stenosis of the responsible middle cerebral artery [M1] confirmed by high-resolution MRI examination (referred to Warfarin-Aspirin Symptomatic Intracranial Disease standard); new-onset infarction confirmed by diffusion weighted imaging (DWI) or TIA symptoms in the territory of the responsible artery supply;
- NIHSS ≤ 20;
- mRS ≤ 2 at randomization (pre-morbid historical assessment);
- Participants understand the purpose of the study and have signed informed consent form.
Who cannot join
- Presence of intracranial hemorrhage or other pathological brain diseases;
- Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
- Unable to undergo MRI examination;
- Use Butylphthalide during onset between randomization;
- Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, etc;
- Contraindications for the use of clopidogrel or aspirin;
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- Known allergy history of celery or butylphthalide;
- Severe liver dysfunction (aspartate aminotransferase or alanine transaminase > 2 times normal upper limit) or severe renal dysfunction (creatinine value > 1.5 times normal upper limit), heart failure, asthma, etc;
- History of intracranial hemorrhage, coagulation disorders, systemic bleeding, thrombocytopenia, or other hematological disorders;
- Plan to perform other surgical procedures or interventional treatments that may require termination of investigational drug use;
- Severe non-cerebrovascular diseases with an expected survival time less than 3 months;
- Actively participating in another drug or device trial;
- Use any drugs with the same or similar mechanism as Butylphthalide during the follow-up period;
- Unsuitable for this trial from the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jinsheng Zeng, +8613322800657, zengjs@pub.guangzhou.gd.cn
Shihui Xing, +8613602755395, xingshih@mail.sysu.edu.cn
About this study
Official title: Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery (SICAS): a Prospective, Randomized, Double-blinded, Placebo-controlled, Multiple-center Trial.
Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis.
Read the detailed description
The SICAS trial is a prospective, randomized, double-blinded, placebo- controlled, multiple-center trial to evaluate the efficacy of butylphthalide in the reduction of symptomatic atherosclerotic stenosis of middle cerebral artery in acute ischemic stroke patients. A total of approximately 140 patients within 7 days of symptom onset of acute ischemic stroke or transient ischemic attack (TIA) will be enrolled. The participants fulfilling the inclusion criteria will be randomized 1:1 into two groups: 1) the Butylphthalide group will receive Butylphthalide Sodium Chloride injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide soft capsules (0.2g, triple/day) from day 11±3 to day 180. 2) the Placebo group will receive Butylphthalide Placebo injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide Placebo soft capsules (0.2g, triple/day) from day 11±3 to day 180. The study consists of four visits including the day of randomization, day 10±3 when the injection therapy is done, and 90 and 180 days when the oral therapy is finished. The primary end point is the change in degree of atherosclerotic stenosis in the symptomatic middle cerebral artery at 180 days. The atherosclerotic stenosis is evaluated by high-resolution MRI vessel-wall imaging technique. The second end point are rate of recurrence of ischemic stroke or TIA in the qualifying artery within 180 days, the changes in plaque volumes, hemorrhage and enhancement volumes of atherosclerotic plaque in the symptomatic middle cerebral artery, National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), change in cerebral perfusion and concentrations of serum lipid profiles within 180 days.
- Being tested
- Butylphthalide, Placebo
- Keywords
- dl-3-n-Butylphthalide, atherosclerotic stenosis, middle cerebral artery, stroke
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButylphthalideDrug
Also called DL-3-n-butylphthalide
Butylphthalide Sodium Chloride injection for 10±3 days, oral Butylphthalide soft capsules for day 11±3 to day 180.
PlaceboDrug
Also called Blank
Butylphthalide Placebo injection for 10±3 days, oral Butylphthalide Placebo soft capsules for day 11±3 to day 180.
| Study group | Role | What they receive |
|---|---|---|
| Butylphthalide | Experimental | The Butylphthalide group will receive Butylphthalide Sodium Chloride injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide soft capsules (0.2g, triple/day) for day 11±3 to day 180. Receives: Drug: Butylphthalide |
| Placebo | Placebo comparator | The Placebo group will receive Butylphthalide Placebo injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide Placebo soft capsules (0.2g, triple/day) for day 11±3 to day 180. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stenosis degree in the responsible artery
Intracranial atherosclerosis is evaluated by high-resolution MRI vessel-wall imaging technique.
Measured: 180 days
Secondary outcomes (7)
Stroke recurrence
Rate of new-onset ischemic stroke or TIA in the territory of the symptomatic middle cerebral artery within 180 days.
Measured: 180 days
Change in plaque volumes the responsible artery
Change in plaque volumes in the symptomatic middle cerebral artery at 90 days and 180 days.
Measured: 90 days, 180 days
Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery
Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the symptomatic middle cerebral artery at 90 days and 180 days.
Measured: 90 days, 180 days
Changes in National Institutes of Health Stroke Scale (NIHSS)
National Institutes of Health Stroke Scale (NIHSS, range: 0 - 42) at baseline and discharge.
Measured: 10±3 days
Proportion of patients with modified Rankin Scale score (mRS) 0-2
Proportion of patients with modified Rankin Scale score (mRS) 0-2 at 90 days and 180 days.
Measured: 90 days, 180 days
Change in the value of cerebral blood flow (CBF) in the responsible artery territory
Qualitative analysis of regional cerebral blood flow (CBF) in arterial spin labeling sequence in the territory of the symptomatic middle cerebral artery at baseline, 90 days and 180 days.
Measured: 90 days, 180 days
Change in concentrations of serum lipid profiles
Concentrations of total cholesterol, serum triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol at baseline, discharge, 90 days and 180 days.
Measured: 10±3 days, 90 days, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jinsheng Zeng, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331494
- Sponsor's protocol ID
- SICAS
- Acronym
- SICAS
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery (SICAS): a Prospective, Randomized, Double-blinded, Placebo-controlled, Multiple-center Trial.
- ClinicalTrials.gov ID
- NCT06331494
- Acronym / sponsor ID
- SICAS / SICAS
- Keywords
- dl-3-n-Butylphthalide, atherosclerotic stenosis, middle cerebral artery, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Mar 2024 (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.
Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis.
Detailed description
The SICAS trial is a prospective, randomized, double-blinded, placebo- controlled, multiple-center trial to evaluate the efficacy of butylphthalide in the reduction of symptomatic atherosclerotic stenosis of middle cerebral artery in acute ischemic stroke patients. A total of approximately 140 patients within 7 days of symptom onset of acute ischemic stroke or transient ischemic attack (TIA) will be enrolled. The participants fulfilling the inclusion criteria will be randomized 1:1 into two groups: 1) the Butylphthalide group will receive Butylphthalide Sodium Chloride injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide soft capsules (0.2g, triple/day) from day 11±3 to day 180. 2) the Placebo group will receive Butylphthalide Placebo injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide Placebo soft capsules (0.2g, triple/day) from day 11±3 to day 180. The study consists of four visits including the day of randomization, day 10±3 when the injection therapy is done, and 90 and 180 days when the oral therapy is finished. The primary end point is the change in degree of atherosclerotic stenosis in the symptomatic middle cerebral artery at 180 days. The atherosclerotic stenosis is evaluated by high-resolution MRI vessel-wall imaging technique. The second end point are rate of recurrence of ischemic stroke or TIA in the qualifying artery within 180 days, the changes in plaque volumes, hemorrhage and enhancement volumes of atherosclerotic plaque in the symptomatic middle cerebral artery, National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), change in cerebral perfusion and concentrations of serum lipid profiles within 180 days.
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: ButylphthalideThe Butylphthalide group will receive Butylphthalide Sodium Chloride injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide soft capsules (0.2g, triple/day) for day 11±3 to day 180. |
| Placebo | Placebo comparator | Drug: PlaceboThe Placebo group will receive Butylphthalide Placebo injection (100ml, twice/day) for the initial 10±3 days, followed by oral Butylphthalide Placebo soft capsules (0.2g, triple/day) for day 11±3 to day 180. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male aged 55-75 years;
- At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking;
- Symptomatic atherosclerotic stenosis in middle cerebral artery: large artery atherosclerotic cerebral infarction or TIA within 7 days of onset; 70%-99% stenosis of the responsible middle cerebral artery [M1] confirmed by high-resolution MRI examination (referred to Warfarin-Aspirin Symptomatic Intracranial Disease standard); new-onset infarction confirmed by diffusion weighted imaging (DWI) or TIA symptoms in the territory of the responsible artery supply;
- NIHSS ≤ 20;
- mRS ≤ 2 at randomization (pre-morbid historical assessment);
Key exclusion criteria (14 listed)
- Presence of intracranial hemorrhage or other pathological brain diseases;
- Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy;
- Unable to undergo MRI examination;
- Use Butylphthalide during onset between randomization;
- Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, 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: DL-3-n-butylphthalideButylphthalide Sodium Chloride injection for 10±3 days, oral Butylphthalide soft capsules for day 11±3 to day 180. | Drug | Butylphthalide |
| PlaceboAlso: BlankButylphthalide Placebo injection for 10±3 days, oral Butylphthalide Placebo soft capsules for day 11±3 to day 180. | Drug | Placebo |
Primary outcome
Changes in stenosis degree in the responsible artery
Time frame: 180 days
Intracranial atherosclerosis is evaluated by high-resolution MRI vessel-wall imaging technique.
7 secondary outcomes
Stroke recurrence
Time frame: 180 days
Change in plaque volumes the responsible artery
Time frame: 90 days, 180 days
Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery
Time frame: 90 days, 180 days
Changes in National Institutes of Health Stroke Scale (NIHSS)
Time frame: 10±3 days
Proportion of patients with modified Rankin Scale score (mRS) 0-2
Time frame: 90 days, 180 days
Change in the value of cerebral blood flow (CBF) in the responsible artery territory
Time frame: 90 days, 180 days
Change in concentrations of serum lipid profiles
Time frame: 10±3 days, 90 days, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jinsheng Zeng principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butylphthalide in people with Ischemic Stroke, Acute and Intracranial Atherosclerosis, run by First Affiliated Hospital, Sun Yat-Sen University 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 14 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 26 Mar 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. 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.
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 Jinsheng Zeng (+8613322800657, zengjs@pub.guangzhou.gd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stenosis degree in the responsible artery (time frame: 180 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 26 Mar 2024.