Statin Treatment for UnruptureD Intracranial anEurysms Study

Intracranial Aneurysm Clinical Trial

— STUDIES  

Official title:

Application of Atorvastatin in the Treatment of Patients With Intracranial Unruptured Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149483
• Other study ID #: BNI-2019001
• Status: Recruiting
• Phase: Phase 2
• Start date: November 7, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: October 2019
• Source: Beijing Neurosurgical Institute
• Contact: Yisen Zhang, MD
• Phone: +86-010-59978852
• Email: zhang-yisen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Unruptured intracranial aneurysms (UIAs) are increasingly detected and often remain clinically asymptomatic for a long time before rupture. However, once the UIAs ruptured, the incidence of mortality rate varies from 30% to 60% within 6 months. Thus, the risk of UIAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making.

Histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of UIAs. Wall enhancement of a saccular aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial saccular aneurysm.

Statins inhibit 3-hydroxy-3-methylglutaryl coenzyme A reductase and are established first-line treatments for hypercholesterolemia. Statins produce a range of pleiotropic effects in addition to inhibition of cholesterol synthesis, especially to reduce inflammation, which may be important in reducing the growth and rupture of UIAs.

In the study, participants known to have UIA that is not planned for treatment and has not yet ruptured, take atorvastatin daily for six months, and have an HRMRI scan before and after to look for the role of atorvastatin in inflammation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be aged 18 or over, male or non-pregnant female;

2. patients have a saccular UIA identified on imaging (CT, MRI or DSA), and the aneurysm =3mm;

3. patients with wall enhancement of aneurysm by MRI VWI before treatment;

4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.

Exclusion Criteria:

1. Patient with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;

2. Planned treatment of the aneurysm within 6 months;

3. Patient taking the drugs, which might have an anti-inflammatory effect, such as aspirin, statin, immunosuppressive drug, etc.

4. Dyslipidemia or severely 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 disease, congestive heart failure, malignant tumors, etc;

8. Poor compliance patients.

Related Conditions & MeSH terms

• Aneurysm
• Inflammation
• Inflammation Vascular
• Intracranial Aneurysm

Intervention

Drug:
• Atorvastatin
One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.
• Placebos
One with the intervention (Placebo, 20mg OD), 30 patients for this arm.

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods.	Maximum diameter increase = 1mm or appearance of a daughter sac were defined as Change of aneurysmal morphology. An available software for automatic IAs measurement, UKNOW (http://www.unionstrongtech.cn/.), was used to extract and automatically acquire morphological features.	6 months
Secondary	Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods.	Changes/deviations of CRP in mg/L in serum from pre-treatment to after 6 months treatment. Turbidimetric immunoassay will be performed for measurement of CRP. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.	6 months
Secondary	Changes of TNF-a in UIA patients between pre-treatment and the 6 months follow-up periods.	Changes/deviations of TNF-a in pg/ml in serum from pre-treatment to after 6 months treatment. Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.	6 months
Secondary	Changes of IL-1ß in UIA patients between pre-treatment and the 6 months follow-up periods.	Changes/deviations of IL-1ß in pg/ml in serum from pre-treatment to after 6 months treatment. Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.	6 months
Secondary	Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods.	Changes/deviations of IL-6 in pg/ml in serum from pre-treatment to after 6 months treatment. Enzyme-linked immunosorbent assay (ELISA) will be performed for measurement. A blood sample will be drawn from the brachial vein at a fixed time in the morning before breakfast.	6 months