NCT04149483

Brief Summary

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral 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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

October 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 1, 2020

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

October 30, 2019

Last Update Submit

April 29, 2020

Conditions

Intracranial AneurysmInflammation Vascular

Keywords

High resolution magnetic resonanceAtorvastatinRuptured risk

Outcome Measures

Primary Outcomes (1)

  • The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI).

    The change in aneurysm wall enhancement index of at least 20% on MRI vessel wall imaging (VWI) at the end of 6 months of atorvastatin 20mg daily treatment, compared to no treatment.

    6 months

Secondary Outcomes (5)

  • Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods.

    6 months

  • Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods.

    6 months

  • Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods.

    6 months

  • Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods.

    6 months

  • Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods.

    6 months

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Atorvastatin tablets, 20mg once a day, for six months.

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Same color and size coated tablet, 20mg once a day, for six months.

Drug: Placebos

Interventions

AtorvastatinDRUG

One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.

Atorvastatin
PlacebosDRUG

One with the intervention (Placebo, 20mg OD), 30 patients for this arm.

Placebo

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 saccular UIA identified on imaging (CT, MRI or DSA), and the aneurysm ≥3mm;
  • patients with wall enhancement of aneurysm by MRI VWI before treatment;
  • patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.

You may not qualify if:

  • Patient with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;
  • Planned treatment of the aneurysm within 6 months;
  • Patient taking the drugs, which might have an anti-inflammatory effect, such as aspirin, statin, immunosuppressive drug, etc.
  • Dyslipidemia or severely impaired liver or renal functions
  • Retreatment of recurrent aneurysm;
  • Pregnant or lactating women;
  • Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
  • Poor compliance patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

  • Li W, Zhang Y, Tian Z, Zhu W, Liu J, Zhang Y, Yang X, Tian DC. Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial. Stroke Vasc Neurol. 2020 Dec;5(4):410-415. doi: 10.1136/svn-2020-000353. Epub 2020 May 6.

    PMID: 32381630DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Yisen Zhang, MD

CONTACT

+86-010-59978852zhang-yisen@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 4, 2019

Study Start

November 7, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 1, 2020

Record last verified: 2019-10

Locations

CN(1)