Cerebrovascular OcclusionPhase 4INCIMONCT02594995
The Impact of NBP on the Collateral Circulation in ICA/M1 Occlusion
A Phase 4 study testing NBP in people with Cerebrovascular Occlusion and Collateral Blood Circulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Occlusion, Collateral Blood Circulation, Anterior Cerebral Circulation Infarction
- What is being tested?
- NBP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to 30 Dec 2019
- 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
- Men or women ≥ 18 years old;
- Acute occlusion of M1 or intracranial internal carotid artery within 72 hours;
- For patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1;
- Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4;
- Baseline mRS before this stroke onset less than 2;
- Able and willing to comply with study requirements;
- Signed informed consent by patients self or legally authorized representatives.
Who cannot join
- Cerebral hemorrhage;
- Posterior circulation infarction;
- Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura;
- Currently using urinary kallidinogenase or alprostadil;
- Be allergic to NBP or celery;
- Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
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- Patients with evidence of severe congestive heart failure or history of end-stage cardiovascular disease (e.g. congestive heart failure New York Heart Association Class III or IV);
- Metastatic neoplasm or multiple organ failure;
- Pregnancy or breastfeeding;
- History of mental instability or dementia.
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion
Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the Circle of Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with infarct growth. The presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.
- Conditions
- Cerebrovascular Occlusion, Collateral Blood Circulation, Anterior Cerebral Circulation Infarction
- Being tested
- NBP
- Medical subject headings
- Cerebrovascular Disorders, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBPDrug
| Study group | Role | What they receive |
|---|---|---|
| NBP in thrombolysis group | Experimental | NBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis Receives: Drug: NBP |
| NBP group | Experimental | NBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA Receives: Drug: NBP |
| Control group | No intervention | Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy |
| Control in thrombolysis group | No intervention | Control group receiving rt-PA thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Measured: 3 months
Secondary outcomes (5)
rLMC scale of Collateral circulation
We use regional leptomeningeal score(rLMC) score to measure collateral circulation.rLMC score is based on scoring pial and lenticulostriate arteries in 6 ASPECTS regions(M1-6) plus anterior cerebral artery region and basal ganglia. Pial arteries in the Sylvian sulcus are scored 0,2, or 4.
Measured: 2 weeks, 3 months
NIHSS score
Measured: 1 week, 2 weeks, 3 months
Hemorrhageic complications including intracranial, digestive tract
Measured: 2 weeks, 3 months
New stroke or transient ischemic attack(TIA)
Measured: 3 months
complete blood count
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completion1 Sep 2016
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular OcclusionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Lou, Ph.D, M.D., Study chair, second affiliated hospital of Zhejiang University, school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594995
- Sponsor's protocol ID
- SAHZJUNeuro
- Acronym
- INCIMO
- Status last verified
- Apr 2016
- First submitted
- 22 Oct 2015
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of NBP on the Collateral Circulation in Acute Acute Internal Carotid Artery(ICA)/Middle Cerebral Artery(M1) Occlusion
- ClinicalTrials.gov ID
- NCT02594995
- Acronym / sponsor ID
- INCIMO / SAHZJUNeuro
- Conditions
- Cerebrovascular Occlusion, Collateral Blood Circulation, Anterior Cerebral Circulation Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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.
Stroke is the first leading cause of death in China, and is responsible for almost 22.4% of deaths. In approximately 80% of cases stroke is ischaemic, i.e. caused by disruption of blood flow to part of the brain from an acute arterial occlusion. Survival of penumbral tissue distal to an arterial occlusion depends on collateral circulation via the Circle of Willis and leptomeningeal anastomises. Collateral flow is dynamic and failure is associated with infarct growth. The presence of adequate collaterals has been shown to be associated with age, history of statin use, and non-hypertension. Dl-3-n-butylphthalide (NBP), isolated from the seeds of celery, and found to exert protective effects against ischemic brain and increase leptomeningeal blood flow. This study investigate whether NBP injection prescribed during acute stroke will have a significant effect to improve collateral circulation in patients of anterior circulation occlusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NBP in thrombolysis group | Experimental | Drug: NBPNBP 25mg bid for 2 weeks administered after 24 hours after receiving recombinant plasminogenactivator(rt-PA) thrombolysis |
| NBP group | Experimental | Drug: NBPNBP 25mg bid for 2 weeks administered for the patients who do not receive rt-PA |
| Control group | No intervention | –Control group not receiving rt-PA thrombolysis, receiving basic therapy for acute stroke, e.g. aspirin/clopidogrel and lipid-lowering therapy |
| Control in thrombolysis group | No intervention | –Control group receiving rt-PA thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women ≥ 18 years old;
- Acute occlusion of M1 or intracranial internal carotid artery within 72 hours;
- For patients who receive recombinant tissue-type plasminogenactivator therapy, the arterial occlusive lesion scale of 24-72 hours post-thrombolysis imaging should be 0 or 1;
- Ischemic stroke with National Institutes of Health Stroke Scale ≥ 4;
- Baseline mRS before this stroke onset less than 2;
Key exclusion criteria (10 listed)
- Cerebral hemorrhage;
- Posterior circulation infarction;
- Severe tendency of hemorrhage, such as thrombocytopenia, leukemia, allergic purpura;
- Currently using urinary kallidinogenase or alprostadil;
- Be allergic to NBP or celery;
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 |
|---|---|---|
| NBP | Drug | NBP group, NBP in thrombolysis group |
Primary outcome
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
Time frame: 3 months
5 secondary outcomes
rLMC scale of Collateral circulation
Time frame: 2 weeks, 3 months
NIHSS score
Time frame: 1 week, 2 weeks, 3 months
Hemorrhageic complications including intracranial, digestive tract
Time frame: 2 weeks, 3 months
New stroke or transient ischemic attack(TIA)
Time frame: 3 months
complete blood count
Time frame: 3 months
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 31 Mar 2020.
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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.
Min Lou, Ph.D, M.D. study chair
second affiliated hospital of Zhejiang University, school of medicine
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 NBP in people with Cerebrovascular Occlusion and Collateral Blood Circulation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 10 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 31 Mar 2020. 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?
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 percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2 (time frame: 3 months). 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 31 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.