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Atorvastatin in the TREATment of Intracranial Unruptured VertebroBasilar Dissecting Aneurysms (ATREAT-VBD)

Primary Purpose

Dissecting Aneurysm of Cerebral Artery, Intramural Hematomas, Inflammation Vascular

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atorvastatin 20mg
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dissecting Aneurysm of Cerebral Artery focused on measuring High resolution magnetic resonance, Atorvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be aged 18 or over, male or non-pregnant female;
  2. Patients have a unruptured vertebrobasilar dissecting aneurysm identified on imaging (CT, MRI or DSA)
  3. Patients with wall enhancement and intramural hematomas of UVBDAs by HR-VW-MRI before treatment.
  4. Patients who is able to understand the objective of the trail, agrees and signs the written informed consent form.

Exclusion Criteria:

  1. The aneurysm types of non-dissecting aneurysm, such as saccular aneurysms, fusiform aneurysms and traumatic aneurysms, etc.;
  2. Patients with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;
  3. Planned treatment of the aneurysm within 6 months;
  4. Several impaired liver or renal functions;
  5. Retreatment of recurrent aneurysm;
  6. Pregnant or lactating women;
  7. Patients with malignant diseases, such as liver disease, kidney diseases, congestive heart failure, malignant tumors, etc.;
  8. Poor compliance patients;

Sites / Locations

  • Beijing Neurosurgical Institute and Beijing Tiantan HospitalRecruiting
  • Mirzat Turhon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Atorvastatin

No drug

Arm Description

Atorvastatin, 20mg once a day, for six months

no drug

Outcomes

Primary Outcome Measures

1.Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.

Secondary Outcome Measures

Change of aneurysmal morphology parameter (the largest diamater)
Change of aneurysmal morphology parameter between pre-treatment and the 6 months follow-up periods.
Change of wall features of UVBDAs
Change of wall features of UVBDAs, which is intramural hematoma between pre-treatment and the 6 months follow-up periods. (The maximum diameter of the false lumen was compared)
Change of inflammatory markers in UVBDAs patients
Change of inflammatory markers in UVBDAs patients between pre-treatment and the 6 months follow-up periods. (CRP, TNF alpha, IL-2,6,8,10 and IL-1 beta)

Full Information

First Posted
May 31, 2021
Last Updated
March 28, 2022
Sponsor
Beijing Neurosurgical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04943783
Brief Title
Atorvastatin in the TREATment of Intracranial Unruptured VertebroBasilar Dissecting Aneurysms
Acronym
ATREAT-VBD
Official Title
Application of Atorvastatin in the TREATment of Patients With Intracranial Unruptured Vertebrobasilar Dissecting Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Neurosurgical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin.
Detailed Description
Unruptured vertebrobasilar dissecting aneurysms (UVBDAs) are a pathological condition of the vertebrobasilar artery caused by hypertension, atherosclerosis, and infection. Hematoma between intima and media can progressively occlude the parent artery. Thus lead to decreasing perfusion of the distal perforator vessels and even cause cerebral infarction. Even worse, ruptured VBDAs can lead to subarachnoid hemorrhage and eventually death of the patients. Thus, risk of UVBDAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making. Recently, many histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of aneurysms. High-resolution vessel wall MRI (HR-VW-MRI) has been increasingly applied in clinical practice and is the only noninvasive method for imaging the structure of the vascular wall. Wall enhancement of an aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial aneurysm. Besides, a previous study has demonstrated that HR-MRI can provide valuable information, such as parameters of intramural hematomas, double lumens and intimal flaps, in the diagnosis and follow-up UVBDAs. Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are widely used cholesterol-lowering drugs and are established as first-line treatments for hypercholesterolemia. In addition, statins exert pleiotropic effects to protect the vasculature. Statins can reduce the inflammation of the vessel wall and mobilize endothelial progenitor cells for aneurysmal endothelial cell repair. Statins can also inhibit the expression of several matrix metalloproteinases by smooth muscle cells and macrophages, which may be important in reducing the growth and rupture of UVBDAs. In this study, participants with UVBDAs that are not planned for surgical treatment and has not yet ruptured, take atorvastatin daily for six months, and have a HRMRI scan before and after conservative therapy to look for the role of atorvastatin in inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dissecting Aneurysm of Cerebral Artery, Intramural Hematomas, Inflammation Vascular
Keywords
High resolution magnetic resonance, Atorvastatin

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin, 20mg once a day, for six months
Arm Title
No drug
Arm Type
No Intervention
Arm Description
no drug
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Intervention Description
One with the intervention (Atorvastatin, 20mg OD), 20 patients for this arm.
Primary Outcome Measure Information:
Title
1.Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Description
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of aneurysmal morphology parameter (the largest diamater)
Description
Change of aneurysmal morphology parameter between pre-treatment and the 6 months follow-up periods.
Time Frame
6 months
Title
Change of wall features of UVBDAs
Description
Change of wall features of UVBDAs, which is intramural hematoma between pre-treatment and the 6 months follow-up periods. (The maximum diameter of the false lumen was compared)
Time Frame
6 months
Title
Change of inflammatory markers in UVBDAs patients
Description
Change of inflammatory markers in UVBDAs patients between pre-treatment and the 6 months follow-up periods. (CRP, TNF alpha, IL-2,6,8,10 and IL-1 beta)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be aged 18 or over, male or non-pregnant female; Patients have a unruptured vertebrobasilar dissecting aneurysm identified on imaging (CT, MRI or DSA) Patients with wall enhancement and intramural hematomas of UVBDAs by HR-VW-MRI before treatment. Patients who is able to understand the objective of the trail, agrees and signs the written informed consent form. Exclusion Criteria: The aneurysm types of non-dissecting aneurysm, such as saccular aneurysms, fusiform aneurysms and traumatic aneurysms, etc.; Patients with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.; Planned treatment of the aneurysm within 6 months; Several impaired liver or renal functions; Retreatment of recurrent aneurysm; Pregnant or lactating women; Patients with malignant diseases, such as liver disease, kidney diseases, congestive heart failure, malignant tumors, etc.; Poor compliance patients;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirzat Turhon, MD
Phone
+8618699158800
Email
18699158800@163.com
Facility Information:
Facility Name
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yisen Zhang, MD
Phone
+86-010-59978852
Email
zhang-yisen@163.com
First Name & Middle Initial & Last Name & Degree
Mirzat Turhon, MD
Phone
+86-18699158800
Email
18699158800@163.com
Facility Name
Mirzat Turhon
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirzat Turhon, MD
Phone
+86-010-59978852
Email
18699158800@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available on reasonable request.
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Data are available on reasonable request.
Citations:
PubMed Identifier
35487525
Citation
Turhon M, Kang H, Huang J, Li M, Liu J, Zhang Y, Wang K, Yang X, Zhang Y. Atorvastatin for unruptured intracranial vertebrobasilar dissecting aneurysm (ATREAT-VBD): protocol for a randomised, double-blind, blank-controlled trial. BMJ Open. 2022 Apr 28;12(4):e059616. doi: 10.1136/bmjopen-2021-059616.
Results Reference
derived

Learn more about this trial

Atorvastatin in the TREATment of Intracranial Unruptured VertebroBasilar Dissecting Aneurysms

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