Cerebral Arteriovenous MalformationPhase 2NCT04297033
Lovastatin for Treatment of Brain Arteriovenous Malformations
A Phase 2 study testing Lovastatin in people with Cerebral Arteriovenous Malformation, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Arteriovenous Malformation
- What is being tested?
- Lovastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,244 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jun 2024
- 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
- Patient must have BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- BAVM deemed unsuitable for invasive treatment OR patient has elected to defer invasive treatment
- Patient must be 18 years of age or older
- Sign the informed consent
Who cannot join
- Patient has received prior BAVM interventional therapy (endovascular, surgical, radiotherapy)
- Patient has multiple-foci BAVMs
- Patient has any form of arteriovenous or spinal fistulas
- Previous diagnosis of any of the following -
- Patient was diagnosed with Vein of Galen type malformation
- Patient was diagnosed with cavernous malformation
Show all 25Show fewer
- Patient was diagnosed with dural arteriovenous fistula
- Patient was diagnosed with venous malformation
- Patient was diagnosed with neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- Patient was diagnosed with BAVMs in context of moya-moya-type changes
- Patient was diagnosed with hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
- Contraindication to an HMG-coA-reductase inhibitor
- History of adverse reaction to HMG-coA-reductase inhibitors (rhabdomyolysis, hepatitis)
- Use of any cholesterol lowering medication in the previous 12 weeks
- Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this treatment
- Impaired liver function with aspartate transaminase (AST) or alanine transaminase (ALT) is more than twice limit of normal.
- Creatine kinase (CK) is more than twice limit of normal.
- Medications that interfere with the metabolism of lovastatin
- Gastrointestinal disease that would affect the ability to swallow or take oral medications or absorb them.
- End stage renal disease (creatinine clearance eGFR <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
- Patient has a history of chronic alcohol or drug abuse within 2 years prior to being recruited
- Patient has known allergy against iodine contrast agents
- Patient is pregnant or lactating
- Inability to provide informed consent.
- Participation in any clinical investigation within 2 months prior to dosing
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Yong Cao, MD, 861067096510 ext. 100050, caoyong6@hotmail.com
About this study
Official title: Lovastatin for Treatment of Brain Arteriovenous Malformations:a Double-blind, Placebo-controlled Randomized Trial
The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation.
Read the detailed description
Brain arteriovenous malformations are lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. As the disease progresses, the lesion may cause several adverse clinical events including stroke, seizure or even death. For patients with BAVM deemed unsuitable for invasive treatment or who has elected to defer invasive treatment, it is essential to take effective medical management.
Lovastatin possesses antiinflammatory and antiproliferative actions in human endothelial and vascular smooth muscle cells independent of its lipid-lowing action. These findings suggest that lovastatin may be beneficial for maintaining vascular stability, which may contribute to slowing down the progression of the disease and reducing the incidence of adverse clinical events.
The purpose of this pilot study is to evaluate the safety and disease-modifying efficacy of lovastatin in patients with BAVMs. Participants will be randomly assigned to receive either combination of lovastatin and symptomatic treatment drugs or combination of placebo and symptomatic treatment drugs. Patients will have post-dose safety follow-up visit at 1, 3, 6, and 12 months after the study begins. The changes in clinical outcomes, including lesion volume changes and the rate of stroke, seizure or death, will be evaluated in a period of 2 years.
- Conditions
- Cerebral Arteriovenous Malformation
- Being tested
- Lovastatin, Placebo
- Keywords
- Cerebral Arteriovenous Malformation, Lovastatin
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovastatinDrug
lovastatin 40mg/d 12m
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Lovastatin intervention | Experimental | combination of 40mg/d 12m lovastatin and symptomatic treatment drugs as a treatment strategy for BAVM . Receives: Drug: Lovastatin |
| placebo | Placebo comparator | combination of placebo and symptomatic treatment drugs as a treatment strategy for BAVM Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of stroke between two arms
Stroke is defined as a clinically symptomatic event (any new focal neurological deficit, seizure, or new-onset headache) that is associated with imaging findings of haemorrhage or infarction. Haemorrhage is defined as fresh intracranial blood on head CT or MRI, or in the cerebrospinal fluid. Infarction is defined as a new ischaemic lesion on cranial CT or MRI (diffusion-weighted, T2-weighted, or fluid-attenuated inversion recovery MRI).
Measured: 24 months
Secondary outcomes (2)
Change in AVM volume from baseline MRI
The volume of arteriovenous malformations will be measured by using MRIcron. The brain arteriovenous malformations will be traced directly on the brain MRIs using MRIcron. Masks of the brain arteriovenous malformations will be drawn on each patient's T1 image in native space by board-certified neurosurgeons, who are blinded to the patients' clinical information. Then, the volume of arteriovenous malformations can be calculated by MRIcron.
Measured: baseline, 6 months, 12 months, 18 months, 24 months
Changes in the incidence of seizures and death between two arms
Seizures and death are caused by lesions.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297033
- Sponsor's protocol ID
- AVM-lovastatin
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lovastatin for Treatment of Brain Arteriovenous Malformations:a Double-blind, Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04297033
- Acronym / sponsor ID
- AVM-lovastatin
- Conditions
- Cerebral Arteriovenous Malformation
- Keywords
- Cerebral Arteriovenous Malformation, Lovastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,244 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 Mar 2020 (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.
The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation.
Detailed description
Brain arteriovenous malformations are lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. As the disease progresses, the lesion may cause several adverse clinical events including stroke, seizure or even death. For patients with BAVM deemed unsuitable for invasive treatment or who has elected to defer invasive treatment, it is essential to take effective medical management.
Lovastatin possesses antiinflammatory and antiproliferative actions in human endothelial and vascular smooth muscle cells independent of its lipid-lowing action. These findings suggest that lovastatin may be beneficial for maintaining vascular stability, which may contribute to slowing down the progression of the disease and reducing the incidence of adverse clinical events.
The purpose of this pilot study is to evaluate the safety and disease-modifying efficacy of lovastatin in patients with BAVMs. Participants will be randomly assigned to receive either combination of lovastatin and symptomatic treatment drugs or combination of placebo and symptomatic treatment drugs. Patients will have post-dose safety follow-up visit at 1, 3, 6, and 12 months after the study begins. The changes in clinical outcomes, including lesion volume changes and the rate of stroke, seizure or death, will be evaluated in a period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovastatin intervention | Experimental | Drug: Lovastatincombination of 40mg/d 12m lovastatin and symptomatic treatment drugs as a treatment strategy for BAVM . |
| placebo | Placebo comparator | Drug: Placebocombination of placebo and symptomatic treatment drugs as a treatment strategy for BAVM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- BAVM deemed unsuitable for invasive treatment OR patient has elected to defer invasive treatment
- Patient must be 18 years of age or older
- Sign the informed consent
Key exclusion criteria (25 listed)
- Patient has received prior BAVM interventional therapy (endovascular, surgical, radiotherapy)
- Patient has multiple-foci BAVMs
- Patient has any form of arteriovenous or spinal fistulas
- Previous diagnosis of any of the following -
- Patient was diagnosed with Vein of Galen type malformation
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 |
|---|---|---|
| Lovastatinlovastatin 40mg/d 12m | Drug | Lovastatin intervention |
| Placeboplacebo | Drug | placebo |
Primary outcome
Change in the incidence of stroke between two arms
Time frame: 24 months
Stroke is defined as a clinically symptomatic event (any new focal neurological deficit, seizure, or new-onset headache) that is associated with imaging findings of haemorrhage or infarction. Haemorrhage is defined as fresh intracranial blood on head CT or MRI, or in the cerebrospinal fluid. Infarction is defined as a new ischaemic lesion on cranial CT or MRI (diffusion-weighted, T2-weighted, or fluid-attenuated inversion recovery MRI).
2 secondary outcomes
Change in AVM volume from baseline MRI
Time frame: baseline, 6 months, 12 months, 18 months, 24 months
Changes in the incidence of seizures and death between two arms
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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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 Lovastatin in people with Cerebral Arteriovenous Malformation, run by Beijing Tiantan Hospital 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 25 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 9 Mar 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 Yong Cao, MD (861067096510 ext. 100050, caoyong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of stroke between two arms (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020.