Collateral CirculationPhase 4NCT04091412
Study of Collateral Circulation in Patients With Symptomatic Intracranial Anterior Circulation Occlusion
A Phase 4 study testing Butylphthalide Soft Capsules in people with Collateral Circulation and Large-artery Occlusion, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
Intracranial artery stenosis is the leading cause of stroke onset or recurrence in Asian. Multiple studies have shown that anterior circulation is most common in intracranial artery stenosis, especially the middle cerebral artery in patients with symptomatic or asymptomatic ischemic stroke. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Collateral Circulation, Large-artery Occlusion, Cerebral Infarction
- What is being tested?
- Butylphthalide Soft Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2019to 1 May 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery were diagnosed by CTA; 2 complete medical records;
Who cannot join
- 1. CTA showed no arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery; 2. Follow-up interventional surgery; 3. Death within 30 days of onset; 4. Clinical data incomplete; 5. Loss of follow-up patient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second hospital of hebei medical university
Shijiazhuang, Hebei, 050000
Xiaoyun Liu, Prf., +8613191887318, audrey-l@163.com
About this study
Official title: Study of Collateral Circulation and Related Gene Polymorphism in Patients With Symptomatic Intracranial Anterior Circulation Aortic Occlusion
Intracranial artery stenosis is the leading cause of stroke onset or recurrence in Asian. Multiple studies have shown that anterior circulation is most common in intracranial artery stenosis, especially the middle cerebral artery in patients with symptomatic or asymptomatic ischemic stroke. Based on the clinical experiences, we found that the cerebral collateral development can affect clinical symptoms seriously in patients with large artery stenosis. Compensated blood flow can reach the ischemic area through collateral circulation (including circle of Willis, leptomeningeal collaterals, extracranial to intracranial collaterals, and new angiogenesis) when the blood-supplying artery of the brain is severely stenotic or even occluded, however, considerable differences across individuals exist. Studies have shown statins and butylphthalide can promote collateral circulation. The influencing factors on collateral circulation building have not been completely identified yet, but a recent research found that Naturally occurring variants of Rabep2（Rab GTPase binding effector protein 2）are major determinants of variation in collateral extent and stroke severity in mice. On this basis, clinical trials have been conducted in order to confirm that the Rabep2 gene is associated with individual differences in the collateral circulation.
Summarizing new findings, we suspect whether the difference in the degree of collateral circulation is significant for long-term prognosis in patients with cerebral large arterial occlusion, and whether promoting collateral circulation and new angiogenesis can become a new treatment approach. Hereby, we plan to recruit 500 patients with cerebral large-artery occlusion, collect clinical and Imaging (CTA) information, analyze and investigate if the difference in the degree of collateral circulation can be the independent influencing factor for long-term prognosis. This study will collect blood sample of patients and further examine SNPs of Rabep2, and will then analyze the correlation between Rabep2 and patients with cerebral large-artery occlusion. This project will follow up rolled patients for 1 year, observe if long-term intake of butylphthalide can promote cerebral collateral development.
- Being tested
- Butylphthalide Soft Capsules
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butylphthalide Soft CapsulesDrug
Also called NBP
The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.
| Study group | Role | What they receive |
|---|---|---|
| Long-term administration of Butylphthalide Soft Capsules | Experimental | In addition to standard secondary preventive drugs, such as atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets, patients in this group take Butylphthalide Soft Capsules orally, 0.2g per serving, three times a day for one year. Receives: Drug: Butylphthalide Soft Capsules |
| Standard secondary prevention group | No intervention | patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
collateral circulation level
Evaluation of collateral circulation level based on CTA
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start5 May 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Collateral CirculationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liuxiaoyun, The Second Hospital of Hebei Medical University
- Investigators
- Xiaoyun Liu, Prf., Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091412
- Sponsor's protocol ID
- 2019-P012
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang K, Liu L, Li T, Wang R, Bu K, Zhao P, Liu X. Collateral Circulation and Rabep2 Polymorphisms in Large Artery Occlusion: Impacts on Short- and Long-Term Prognosis. J Am Heart Assoc. 2025 Apr 15;14(8):e040032. doi: 10.1161/JAHA.124.040032. Epub 2025 Apr 10.
PubMed 40207533
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Collateral Circulation and Related Gene Polymorphism in Patients With Symptomatic Intracranial Anterior Circulation Aortic Occlusion
- ClinicalTrials.gov ID
- NCT04091412
- Acronym / sponsor ID
- 2019-P012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 16 Sep 2019 (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.
Intracranial artery stenosis is the leading cause of stroke onset or recurrence in Asian. Multiple studies have shown that anterior circulation is most common in intracranial artery stenosis, especially the middle cerebral artery in patients with symptomatic or asymptomatic ischemic stroke. Based on the clinical experiences, we found that the cerebral collateral development can affect clinical symptoms seriously in patients with large artery stenosis. Compensated blood flow can reach the ischemic area through collateral circulation (including circle of Willis, leptomeningeal collaterals, extracranial to intracranial collaterals, and new angiogenesis) when the blood-supplying artery of the brain is severely stenotic or even occluded, however, considerable differences across individuals exist. Studies have shown statins and butylphthalide can promote collateral circulation. The influencing factors on collateral circulation building have not been completely identified yet, but a recent research found that Naturally occurring variants of Rabep2（Rab GTPase binding effector protein 2）are major determinants of variation in collateral extent and stroke severity in mice. On this basis, clinical trials have been conducted in order to confirm that the Rabep2 gene is associated with individual differences in the collateral circulation.
Summarizing new findings, we suspect whether the difference in the degree of collateral circulation is significant for long-term prognosis in patients with cerebral large arterial occlusion, and whether promoting collateral circulation and new angiogenesis can become a new treatment approach. Hereby, we plan to recruit 500 patients with cerebral large-artery occlusion, collect clinical and Imaging (CTA) information, analyze and investigate if the difference in the degree of collateral circulation can be the independent influencing factor for long-term prognosis. This study will collect blood sample of patients and further examine SNPs of Rabep2, and will then analyze the correlation between Rabep2 and patients with cerebral large-artery occlusion. This project will follow up rolled patients for 1 year, observe if long-term intake of butylphthalide can promote cerebral collateral development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term administration of Butylphthalide Soft Capsules | Experimental | Drug: Butylphthalide Soft CapsulesIn addition to standard secondary preventive drugs, such as atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets, patients in this group take Butylphthalide Soft Capsules orally, 0.2g per serving, three times a day for one year. |
| Standard secondary prevention group | No intervention | –patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery were diagnosed by CTA; 2 complete medical records;
Key exclusion criteria (1 listed)
- 1. CTA showed no arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery; 2. Follow-up interventional surgery; 3. Death within 30 days of onset; 4. Clinical data incomplete; 5. Loss of follow-up patient.
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 |
|---|---|---|
| Butylphthalide Soft CapsulesAlso: NBPThe first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation. | Drug | Long-term administration of Butylphthalide Soft Capsules |
Primary outcome
collateral circulation level
Time frame: 1 hour
Evaluation of collateral circulation level based on CTA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Derived from this study: PubMed 40207533Zhang K, Liu L, Li T, Wang R, Bu K, Zhao P, Liu X. Collateral Circulation and Rabep2 Polymorphisms in Large Artery Occlusion: Impacts on Short- and Long-Term Prognosis. J Am Heart Assoc. 2025 Apr 15;14(8):e040032. doi: 10.1161/JAHA.124.040032. Epub 2025 Apr 10.
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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.
Xiaoyun Liu, Prf. principal investigator
The Second Hospital of Hebei Medical University
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 Soft Capsules in people with Collateral Circulation and Large-artery Occlusion, run by The Second Hospital of Hebei Medical 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2019. 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 Kun Zhang, Dr. (+8618633922056, miraimail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collateral circulation level (time frame: 1 hour). 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 NCT04091412, which also lists 1 linked publication.
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 16 Sep 2019.