Status:
UNKNOWN
Lovastatin for Treatment of Brain Arteriovenous Malformations
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Cerebral Arteriovenous Malformation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
1244 Patients enrolled
Trial Details
Trial ID
NCT04297033
Start Date
January 1 2021
End Date
June 1 2024
Last Update
March 9 2020
Active Locations (1)
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1
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100050