Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01756833
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2012-12-20
Brief Title:
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial N-TA3CT
Status:
COMPLETED
Status Verified Date:
2021-10
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:
N-TA3CT
Brief Summary:
The primary aim of this study is to determine if doxycycline 100 mg bid will inhibit by at least 40 the increase in greatest transverse diameter of small abdominal aortic aneurysms 35-50 cm in men 35-45 cm in women over a 24-month period of observation in comparison to a placebo-treated control group
Detailed Description:
N-TA3CT is a randomized double-blind placebo-controlled test of the hypothesis that doxycycline 100 mg bid will reduce the rate of increase of maximum transverse diameter of small 35-50 cm among men and 35 to 45 cm among women abdominal aortic aneurysms The primary outcome is abdominal aortic aneurysm AAA maximum transverse diameter determined by CT scans at two-year follow-up with allowance for baseline pre-randomization diameter Based on an anticipated growth rate of 25 mm per year in the placebo group and the current threshold at which surgical intervention will be offered to trial participants 55 cm in men 50 cm in women the upper limit of AAA size for inclusion has been set at 50 cm for men and 45 cm for women Among these subjects the threshold for repair would be exceeded only by those exhibiting persistent growth Secondary outcomes will determine if doxycycline affects other measures eg MMP-9 levels in plasma and whether these effects are related to aneurysm growth Nineteen clinical sites have identified pools of over 1600 patients with small aneurysm who meet the proposed inclusionexclusion criteria Two hundred fifty-eight patients will be randomized to placebo or doxycycline and their aneurysms followed for change in diameter at six-month intervals using CT imaging The alternative hypothesis is that doxycycline will inhibit the expansion rate by 40 during the two years of observation Patients enrolling in N-TA3CT must be able to give consent for their participation themselves and meet study eligibility criteria
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG037120 | NIH | None | httpsreporternihgovquickSearchR01AG037120 |