Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Aneurysm

In brief

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.

Key facts

Study ID

NCT01756833

Run by

University of Maryland, Baltimore

People needed

261

Starts

2013-05-01

Expected to finish

2019-07-23

Last updated by the study team

2021-11-26

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona Medical Center — Tucson, Arizona, United States
• Carondelet Heart & Vascular Institute — Tucson, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Miami Cardiac and Vascular Institute — Miami, Florida, United States
• University of South Florida Health Center — Tampa, Florida, United States
• Northwestern University Memorial Hospital — Chicago, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• McLaren Northern Michigan — Petoskey, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Omaha VAMC — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Columbia University Medical Center — New York, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Portland VAMC — Portland, Oregon, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States
• Utah VAMC — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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