Lovastatin for Treatment of Brain Arteriovenous Malformations

NCT04297033 | Unknown Phase 2 DMC

• 1 other identifier: AVM-lovastatin
• Study Type: interventional
• Target: 1,244
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the disease-modifying efficacy of lovastatin in patients with brain arteriovenous malformation.

Conditions

Cerebral Arteriovenous Malformation

Keywords

Cerebral Arteriovenous Malformation, Lovastatin

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (2)

• Change in AVM volume from baseline MRI

  baseline, 6 months, 12 months, 18 months, 24 months

• Changes in the incidence of seizures and death between two arms

  24 months

Study Arms (2)

Lovastatin intervention

EXPERIMENTAL

combination of 40mg/d 12m lovastatin and symptomatic treatment drugs as a treatment strategy for BAVM .

Drug: Lovastatin

placebo

PLACEBO COMPARATOR

combination of placebo and symptomatic treatment drugs as a treatment strategy for BAVM

Drug: Placebo

Interventions

Lovastatin DRUG

lovastatin 40mg/d 12m

Lovastatin intervention

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Yong Cao, MD

CONTACT

861067096510; caoyong6@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

CN (1)