search
Back to results

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

Primary Purpose

Collateral Circulation, Large-artery Occlusion, Cerebral Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Butylphthalide Soft Capsules
Sponsored by
The Second Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Collateral Circulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Second hospital of hebei medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Long-term administration of Butylphthalide Soft Capsules

Standard secondary prevention group

Arm Description

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.

patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention.

Outcomes

Primary Outcome Measures

collateral circulation level
Evaluation of collateral circulation level based on CTA

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
September 13, 2019
Sponsor
The Second Hospital of Hebei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04091412
Brief Title
Study of Collateral Circulation in Patients With Symptomatic Intracranial Anterior Circulation Occlusion
Official Title
Study of Collateral Circulation and Related Gene Polymorphism in Patients With Symptomatic Intracranial Anterior Circulation Aortic Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Hebei Medical University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collateral Circulation, Large-artery Occlusion, Cerebral Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-term administration of Butylphthalide Soft Capsules
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard secondary prevention group
Arm Type
No Intervention
Arm Description
patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention.
Intervention Type
Drug
Intervention Name(s)
Butylphthalide Soft Capsules
Other Intervention Name(s)
NBP
Intervention Description
The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.
Primary Outcome Measure Information:
Title
collateral circulation level
Description
Evaluation of collateral circulation level based on CTA
Time Frame
1 hour

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Zhang, Dr.
Phone
+8618633922056
Email
miraimail@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoyun Liu, Prf.
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second hospital of hebei medical university
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyun Liu, Prf.
Phone
+8613191887318
Email
audrey-l@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs