Intracranial AneurysmPhase 2STUDIESNCT04149483
Statin Treatment for UnruptureD Intracranial anEurysms Study
A Phase 2 study testing Atorvastatin in people with Intracranial Aneurysm and Inflammation Vascular, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Inflammation Vascular
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2019to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Yisen Zhang, MD, +86-010-59978852, zhang-yisen@163.com
About this study
Official title: Application of Atorvastatin in the Treatment of Patients With Intracranial Unruptured Aneurysms
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin.
Read the 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
- Being tested
- Atorvastatin, Placebos
- Keywords
- High resolution magnetic resonance, Atorvastatin, Ruptured risk
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.
PlacebosDrug
One with the intervention (Placebo, 20mg OD), 30 patients for this arm.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin tablets, 20mg once a day, for six months. Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Same color and size coated tablet, 20mg once a day, for six months. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 months
Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods.
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.
Measured: 6 months
Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods.
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start7 Nov 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149483
- Sponsor's protocol ID
- BNI-2019001
- Acronym
- STUDIES
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32381630
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Atorvastatin in the Treatment of Patients With Intracranial Unruptured Aneurysms
- ClinicalTrials.gov ID
- NCT04149483
- Acronym / sponsor ID
- STUDIES / BNI-2019001
- Conditions
- Intracranial Aneurysm, Inflammation Vascular
- Keywords
- High resolution magnetic resonance, Atorvastatin, Ruptured risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin tablets, 20mg once a day, for six months. |
| Placebo | Placebo comparator | Drug: PlacebosSame color and size coated tablet, 20mg once a day, for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinOne with the intervention (atorvastatin, 20mg OD), 30 patients for this arm. | Drug | Atorvastatin |
| PlacebosOne with the intervention (Placebo, 20mg OD), 30 patients for this arm. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 32381630Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Intracranial Aneurysm and Inflammation Vascular, run by Beijing Neurosurgical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yisen Zhang, MD (+86-010-59978852, zhang-yisen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.