Influence of MMP on Brain AVM Hemorrhage
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Arteriovenous Malformations; Brain Cavernous Malformations; Brain Aneurysms
Intervention: Doxycycline or Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Chanhung Lee, MD, Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Nancy J. Quinnine, RN, Phone: 415-476-2677, Email: quinnine@anesthesia.ucsf.edu
Summary
Brain vascular malformations, including arteriovenous malformations (AVM), cavernous
malformations (CVM) and aneurysms, are a source of life-threatening risk of intracranial
hemorrhage. The etiology and pathogenesis are unknown. There is no medical therapy presently
available. Prevention of spontaneous intracerebral hemorrhage (ICH) is the primary reason to
treat brain vascular malformations. The goal of this study is to: begin pilot studies to lay
the groundwork for future clinical trials to develop medical therapy to decrease ICH risk.
Matrix metalloproteinases (MMPs) regulate the extracellular matrix in association with
various hemorrhagic brain disorders. MMP-9 has been most consistently associated with
vascular wall instability and hemorrhagic brain disorders. Doxycycline, a non-specific MMP
inhibitor, may enhance vascular stability, thus reducing the risk of spontaneous hemorrhage
in brain vascular malformations by decreasing MMP-9 activity.
Clinical Details
Official title: Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment
Primary outcome: Our primary aim is to perform a pilot study to document the effect of doxycycline therapy to decrease MMP expression in the vascular malformation tissue.
Secondary outcome: Our secondary aims are: (1) To explore whether plasma MMP-9 levels can be used as a marker for MMP-9 inhibition in the vascular malformation lesional tissue
Detailed description:
- Doses will be randomized by the Pharmacy Department at UCSF for Doxycycline 100 mg/BID
and Placebo BID. These will be prepared in blister-packs.
- Two weeks before surgery, patients will be assigned to a treatment group according to a
random table.
- Each patient will be initially provided with a 2-week supply of drug in blister packs.
The patient will take the final dose of study drug on the morning of surgery.
Baseline labs will be obtained and then again at time of surgery along with a piece of
surgical tissue.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 13 years or older
- Female patients of child bearing age using barrier-type birth control
- Creatinine no greater than 2. 0 mg/di
- Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal
- WBC count at least 3,800/mm3
- BMI within 50% of normal
Exclusion Criteria:
- Allergy to tetracycline
- Unstable medical illness (unstable angina, advanced cancer, etc) over the last 30
days
- Female patients of child-bearing age not using effective birth control (barrier)
- History of vestibular disease (except benign positional vertigo)
- History of noncompliance with treatment or other experimental protocols
- Patients taking other antibiotics
- History of systemic lupus erythematosis
- Patients who are immunocompromised Patients with clinically significant hepatic
dysfunction
Locations and Contacts
Nancy J. Quinnine, RN, Phone: 415-476-2677, Email: quinnine@anesthesia.ucsf.edu
University of California, San Francisco, California 94143, United States; Recruiting
Nancy J. Quinnine, RN, Phone: 415-476-2677, Email: quinnine@anesthesia.ucsf.edu
Chanhung Lee, MD, Principal Investigator
Additional Information
Starting date: March 2008
Last updated: October 30, 2008
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