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Statin Treatment for UnruptureD Intracranial anEurysms Study (STUDIES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149483
Recruitment Status : Unknown
Verified October 2019 by Beijing Neurosurgical Institute.
Recruitment status was:  Recruiting
First Posted : November 4, 2019
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Beijing Neurosurgical Institute

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

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Inflammation Vascular Drug: Atorvastatin Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Atorvastatin in the Treatment of Patients With Intracranial Unruptured Aneurysms
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atorvastatin
Atorvastatin tablets, 20mg once a day, for six months.
Drug: Atorvastatin
One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.

Placebo Comparator: Placebo
Same color and size coated tablet, 20mg once a day, for six months.
Drug: Placebos
One with the intervention (Placebo, 20mg OD), 30 patients for this arm.




Primary Outcome Measures :
  1. The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI). [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods. [ Time Frame: 6 months ]
    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.

  2. Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods. [ Time Frame: 6 months ]
    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.

  3. Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods. [ Time Frame: 6 months ]
    Changes/deviations of TNF-α 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.

  4. Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods. [ Time Frame: 6 months ]
    Changes/deviations of IL-1β 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.

  5. Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods. [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149483


Contacts
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Contact: Yisen Zhang, MD +86-010-59978852 zhang-yisen@163.com

Locations
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China, Beijing
Beijing Neurosurgical Institute and Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100070
Contact: Yisen Zhang, MD    +86-010-59978852    zhang-yisen@163.com   
Sponsors and Collaborators
Beijing Neurosurgical Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT04149483    
Other Study ID Numbers: BNI-2019001
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Neurosurgical Institute:
High resolution magnetic resonance
Atorvastatin
Ruptured risk
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors