Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126204
Status:
COMPLETED
Last Update Posted:
2010-03-04
First Post:
2005-08-02
Brief Title:
Adjunctive Treatment With Doxycycline to Enhance the Durability of Endovascular Aortic Aneurysm Repair
Sponsor:
The Foundation for Barnes-Jewish Hospital
Organization:
Barnes-Jewish Hospital
Study Overview
Official Title:
Adjunctive Treatment With Doxycycline in Endovascular Aneurysm Repair
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Patients will be consented and enrolled at the time of their clinic visit or admission to the hospital for a planned EVAR in accordance with institutional review board guidelines Demographic risk factor and medication regimen data will be obtained from the patients clinical chart Patients will be randomized to doxycycline therapy 100 mg taken twice daily or a placebo The patients will receive their first dose of study medication on the day following surgery and continue the study therapy for 6 months
Plasma and serum will be obtained at the time of enrollment baseline and at each post-operative follow-up visit during the study as outlined above Aliquots will be stored at -80ºC until assayed Measurements of the circulating markers will be performed by commercially available assays for plasma MMP-9 RD Systems Minneapolis MN serum IL-6 RD Systems IL-8 RD Systems IFN-gamma RD Systems and CRP Bio-Check Burlingame CA Data will be collected from the pre-operative and all post-operative CT scans regarding maximal aneurysm diameter and transverse neck diameter at 5 mm 10 mm and 15 mm below the takeoff of the lowest renal artery All documented endoleaks and their clinical type will be recorded as will any re-intervention related to the graft or aneurysm
The primary end-points of the study related to aneurysm measurements will be an increase or decrease in any of the diameter measurements of the aorta by 2 mm or more on 2 consecutive CT scans or a change of 5 mm or more on any single scan Of the circulating markers an additional primary endpoint will be a 50 reduction in baseline MMP-9 after endografting Secondary endpoints will be significant reductions over baseline in circulating IL-6 IL-8 IFN-γ and CRP An a priori power analysis indicates that at 6 months reductions in circulating levels of these markers by 50 can be detected with a β-error of less than 01 and α-error of less than 005
Plasma and serum will be obtained at the time of enrollment baseline and at each post-operative follow-up visit during the study as outlined above Aliquots will be stored at -80ºC until assayed Measurements of the circulating markers will be performed by commercially available assays for plasma MMP-9 RD Systems Minneapolis MN serum IL-6 RD Systems IL-8 RD Systems IFN-gamma RD Systems and CRP Bio-Check Burlingame CA Data will be collected from the pre-operative and all post-operative CT scans regarding maximal aneurysm diameter and transverse neck diameter at 5 mm 10 mm and 15 mm below the takeoff of the lowest renal artery All documented endoleaks and their clinical type will be recorded as will any re-intervention related to the graft or aneurysm
The primary end-points of the study related to aneurysm measurements will be an increase or decrease in any of the diameter measurements of the aorta by 2 mm or more on 2 consecutive CT scans or a change of 5 mm or more on any single scan Of the circulating markers an additional primary endpoint will be a 50 reduction in baseline MMP-9 after endografting Secondary endpoints will be significant reductions over baseline in circulating IL-6 IL-8 IFN-γ and CRP An a priori power analysis indicates that at 6 months reductions in circulating levels of these markers by 50 can be detected with a β-error of less than 01 and α-error of less than 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None