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

NCT04091412 | Unknown Phase 4

• 1 other identifier: 2019-P012
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Collateral Circulation; Large-artery Occlusion; Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• collateral circulation level

  Evaluation of collateral circulation level based on CTA

  1 hour

Study Arms (2)

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.

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.

Interventions

Butylphthalide Soft Capsules DRUG

The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.

Also known as: NBP

Long-term administration of Butylphthalide Soft Capsules

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

Second hospital of hebei medical university

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40207533 DERIVED

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Xiaoyun Liu, Prf.

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Zhang, Dr.

CONTACT

+8618633922056; miraimail@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Neurology Department

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: May 5, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

CN (1)