NCT04149483

Statin Treatment for UnruptureD Intracranial anEurysms Study

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Neurosurgical Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Intracranial Aneurysm
• Inflammation Vascular

Interventions

Type	Name	Description
DRUG	Atorvastatin	One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.
DRUG	Placebos	One with the intervention (Placebo, 20mg OD), 30 patients for this arm.

Timeline

• Start date: 2019-11-07
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2019-11-04
• Last updated: 2020-05-01

Locations

1 site across 1 country: China