Adjunctive Treatment With Doxycycline to Enhance the Durability of Endovascular Aortic Aneurysm Repair
1 other identifier
interventional
75
1 country
1
Brief Summary
The durability of endovascular aneurysm repair (EVAR) has been limited by development of endoleaks which may be secondary to progressive aortic degeneration by matrix metalloproteases (MMP). Doxycycline is a known inhibitor of the MMP family of enzymes in aneurysms. The investigators propose a randomized, controlled trial of adjuvant doxycycline therapy with EVAR to determine its effects on re-intervention, aneurysm shrinkage and serum markers of aneurysmal degeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 3, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMarch 4, 2010
September 1, 2006
August 2, 2005
March 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in aortic measurements by > 2 mm on 2 consecutive scans
Change in aortic measurement by > 5 mm on a single scan
50% reduction in baseline plasma MMP-9 at 6 months
Secondary Outcomes (4)
Significant reductions at 6 months in serum interleukin-6 (IL-6)
Significant reductions at 6 months in serum IL-8
Significant reductions at 6 months in serum interferon-gamma
Significant reductions at 6 months in serum C-reactive protein
Interventions
Eligibility Criteria
You may qualify if:
- Presence of an abdominal aortic aneurysm (AAA) with a maximum diameter of \> or = 4.5 cm
You may not qualify if:
- Known malignancy not to include prostate cancer or any history of cancer that has not had a recurrence in the last 5 years.
- Hypersensitivity to doxycycline or any of its components
- Pregnancy
- Ruptured AAA
- Extension of covered portion of the graft above the renal arteries
- Previous endoluminal aneurysm repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine / Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Related Publications (1)
Hackmann AE, Rubin BG, Sanchez LA, Geraghty PA, Thompson RW, Curci JA. A randomized, placebo-controlled trial of doxycycline after endoluminal aneurysm repair. J Vasc Surg. 2008 Sep;48(3):519-26; discussion 526. doi: 10.1016/j.jvs.2008.03.064. Epub 2008 Jul 15.
PMID: 18632241RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John A Curci, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 3, 2005
Study Start
March 1, 2004
Study Completion
July 1, 2006
Last Updated
March 4, 2010
Record last verified: 2006-09