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Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial

Description

Abdominal aortic aneurysms (AAAs) are a common and life-threatening condition. The rate of aneurysm growth and the risk of rupture are related to aneurysm size. Aortic diameter is the single best predictor of rupture risk. AAAs are typically asymptomatic and spontaneous rupture of an aneurysm is usually fatal. A number of antibiotics have been proposed as a treatment for AAA with varying rationales. One line of reasoning is that AAA progression is enhanced by secondary infection within the aortic wall. Chlamydia pneumonia has been found in atherosclerotic plaque and the wall of abdominal aortic aneurysms. The tetracycline antibiotics have been studied because of their known inhibition of matrix metalloproteinases (MMP). Although studies in mice and rats have shown that doxycycline can slow down the growth of aneurysms, there have only been a few small studies in humans that have not provided a definitive answer. The purpose of the study is to determine whether doxycycline administration can decrease the rate of growth of small abdominal aortic aneurysms. About 250 participants aged 55 and older with a small abdominal aortic aneurysm will be enrolled in this study; about 20 participants at USC. Participants will be randomized to doxycycline or placebo. Participants will be followed for two years with imaging studies and lab tests for various biomarkers as well as qualify of life questionnaires. in addition, they will be monitored for adverse events. The primary study endpoint is the transverse diameter of the aneurysm over the two year period. Secondary endpoints will include evaluation of biomarkers and quality of life. The sponsor will conduct the statistical analysis to assess the safety and efficacy of doxycycline, the change in size of aneurysm.

Phase

N/A

Inclusion and Exclusion 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.

  • 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.

Sites

Please contact Valentina Rodina to learn more about where you can participate in this trial. Please use the contact form on the right side.

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