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Study of Collateral Circulation in Patients With Symptomatic Intracranial Anterior Circulation Occlusion

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ClinicalTrials.gov Identifier: NCT04091412
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
liuxiaoyun, The Second Hospital of Hebei Medical University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Collateral Circulation Large-artery Occlusion Cerebral Infarction Drug: Butylphthalide Soft Capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Study of Collateral Circulation and Related Gene Polymorphism in Patients With Symptomatic Intracranial Anterior Circulation Aortic Occlusion
Actual Study Start Date : May 5, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
Experimental: Long-term administration of Butylphthalide Soft Capsules
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.
Drug: Butylphthalide Soft Capsules
The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.
Other Name: NBP

No Intervention: Standard secondary prevention group
patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention.



Primary Outcome Measures :
  1. collateral circulation level [ Time Frame: 1 hour ]
    Evaluation of collateral circulation level based on CTA



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091412


Contacts
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Contact: Kun Zhang, Dr. +8618633922056 miraimail@163.com

Locations
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China, Hebei
Second hospital of hebei medical university Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xiaoyun Liu, Prf.    +8613191887318    audrey-l@163.com   
Sponsors and Collaborators
The Second Hospital of Hebei Medical University
Investigators
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Principal Investigator: Xiaoyun Liu, Prf. The Second Hospital of Hebei Medical University

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Responsible Party: liuxiaoyun, Deputy Director of Neurology Department, The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT04091412     History of Changes
Other Study ID Numbers: 2019-P012
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
3-n-butylphthalide
Platelet Aggregation Inhibitors
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs