Influence of MMP on Brain AVM Hemorrhage
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ClinicalTrials.gov Identifier: NCT00783523 |
Recruitment Status
:
Completed
First Posted
: October 31, 2008
Last Update Posted
: August 9, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
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Arteriovenous Malformations Cavernous Angiomas Brain Aneurysms | Drug: Doxycycline or Placebo | Phase 1 |
- 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.
- Depending on enrollment/surgery date, patients will take medication either one to 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 1 or 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
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Active Comparator: Doxycycline
Patients undergoing elective vascular malformation surgery will receive doxycycline100 mg twice a day, a dose shown to effectively decrease MMP or placebo, treatment for two weeks prior to surgery
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Drug: Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Other Names:
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Placebo Comparator: Placebo
Patients undergoing elective vascular malformation surgery will receive doxycycline100 mg twice a day, a dose shown to effectively decrease MMP or placebo, treatment for two weeks prior to surgery
|
Drug: Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Other Names:
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- 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. [ Time Frame: 1 to 2-week pre-operative ]
- 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 [ Time Frame: 1 to 2-week pre operative ]

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783523
United States, California | |
University of California | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Chanhung Lee, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00783523 History of Changes |
Other Study ID Numbers: |
H42145-30334-02 AHA #0730360N |
First Posted: | October 31, 2008 Key Record Dates |
Last Update Posted: | August 9, 2013 |
Last Verified: | August 2013 |
Additional relevant MeSH terms:
Congenital Abnormalities Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Hemorrhage Aneurysm Hemangioma Intracranial Aneurysm Hemangioma, Cavernous Pathologic Processes Vascular Diseases Cardiovascular Diseases Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms |
Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Hemostatic Disorders Hemorrhagic Disorders Hematologic Diseases Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |