Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
Condition: Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: Doxycycline; Placebo
Intervention description: 100 mg po bid; capsule identical to the doxycycline capsule
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abdominal; aortic; aneurysm

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
      (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.
    

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.