NCT04943783

Brief Summary

This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

April 6, 2022

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

May 31, 2021

Last Update Submit

March 28, 2022

Conditions

Dissecting Aneurysm of Cerebral ArteryIntramural HematomasInflammation Vascular

Keywords

High resolution magnetic resonanceAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • Change of aneurysmal morphology parameter （the largest diamater）

    6 months

  • Change of wall features of UVBDAs

    6 months

  • Change of inflammatory markers in UVBDAs patients

    6 months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Atorvastatin, 20mg once a day, for six months

Drug: Atorvastatin 20mg

No drug

NO INTERVENTION

no drug

Interventions

Atorvastatin 20mgDRUG

One with the intervention (Atorvastatin, 20mg OD), 20 patients for this arm.

Atorvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Mirzat Turhon

Beijing, China

NOT YET RECRUITING

Related Publications (2)

  • Zhang Y, Wang C, Dong L, Turhon M, Kang H, Liu J, Duan Y, Tian D, Sui B, Zhang Y, Wang K, Mossa-Basha M, Yang X, Zhu C. Statins Reduce Wall Enhancement at Vessel Wall MRI in Unruptured Vertebrobasilar Dissecting Aneurysms: A Randomized Controlled Trial. Radiology. 2025 Dec;317(3):e242806. doi: 10.1148/radiol.242806.

    PMID: 41432563DERIVED

  • 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.

    PMID: 35487525DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Mirzat Turhon, MD

CONTACT

+861869915880018699158800@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 29, 2021

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

July 30, 2022

Last Updated

April 6, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Data are available on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
starting 6 months after publication
Access Criteria
Data are available on reasonable request.

Locations

CN(2)