Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:55 - Any
Updated:12/23/2017
Start Date:May 2013
End Date:September 2019

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Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA^3CT)

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
(3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison
to a placebo-treated control group.

N-TA^3CT 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 (3.5-5.0 cm among men and 3.5 to 4.5 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 2.5 mm per year in the placebo group and the current
threshold at which surgical intervention will be offered to trial participants, (5.5 cm in
men, 5.0 cm in women), the upper limit of AAA size for inclusion has been set at 5.0 cm for
men and 4.5 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, e.g., 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 inclusion/exclusion 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-TA^3CT must be able to give consent for their participation
themselves and meet study eligibility criteria.

Inclusion Criteria:

- Patients 55 years of age or older, women post-surgical menopause or at least two years
since last menses if natural menopause.

- CT scan documented infrarenal abdominal aortic aneurysm with maximum transverse
diameter larger than 35 mm and no greater than 50 mm, in men, and larger than 35 mm
and no greater than 45 mm in women.

Exclusion Criteria:

- Patients will be excluded from the study if they are unable to give their own informed
consent to participate.

- have symptoms related to abdominal aortic aneurysm.

- have other intra-abdominal vascular pathology that may require repair within 24 months
(e.g., renal artery stenosis, large iliac artery aneurysms, iliac occlusive disease,
aneurysmal involvement of the renal artery).

- have had previous abdominal aortic aneurysm repair by open surgical or endovascular
technique.

- have an active malignancy with life expectancy less than two years.

- have an allergy to tetracycline.

- are currently or have been recently treated (previous six months) with tetracycline
derivatives.

- they are currently taking anti-seizure medicines metabolized by pathways influenced by
doxycycline (e.g., carbamazepine, phenytoin, and barbiturates).

- stage II hypertension (patients whose blood pressure is persistently in the range of
systolic > 160 mm Hg or diastolic > 100 mm Hg despite primary physician's best effort
to achieve adequate therapy.

- have dialysis dependent renal failure or impending dialysis treatment for renal
insufficiency.

- have a chronic infection requiring long-term (> 2 weeks) antibiotics.

- have known genetic syndromes responsible for the abdominal aortic aneurysm (e.g.,
Marfan's Syndrome).

- are under treatment with systemic immunosuppressive agents.

- could become pregnant.

- are not good candidates for clinical trial participation.

- are enrolled in another clinical trial.
We found this trial at
22
sites
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: James Elmore, MD
Phone: 570-271-6369
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Los Angeles, California 90033
213) 740-2311
Phone: 323-442-5988
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-2343
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Ann Arbor, Michigan 48109
Principal Investigator: Jonathan Eliason, MD
Phone: 734-936-5786
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Robert Crawford, MD
Phone: 410-328-5840
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Boston, Massachusetts 02215
Principal Investigator: Mark Wyers, MD
Phone: 617-632-9956
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Chicago, Illinois 60611
Principal Investigator: Mark Eskandari, MD
Phone: 312-695-2714
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Omaha, Nebraska 68105
Phone: 402-559-7300
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Jason MacTaggart, MD
Phone: 402-559-4395
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Petoskey, Michigan 49770
Phone: 231-487-1900
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Portland, Oregon 97227
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Portland, Oregon 97239
Phone: 503-220-8262
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Salt Lake City, Utah 84132
Principal Investigator: Larry Kraiss, MD
Phone: 801-581-8301
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500 Foothill Drive
Salt Lake City, Utah 84132
Phone: 801-581-3495
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-721-6709
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tampa, Florida 33606
Principal Investigator: Murray Shames, MD
Phone: 813-259-0921
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Tucson, Arizona 85724
Principal Investigator: Kay Goshima, MD
Phone: 520-626-6670
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Tucson, Arizona 85745
Phone: 520-628-1400
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