Doxycycline for Stabilization of Abdominal Aortic Aneurysms

Phase 3

Completed

Conditions: abdominal aortic aneurysm
10002363

Registration Number: NL-OMON31047

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

• Patients with an abdominal aortic aneurysm
• The diameter should be 3.5 - 5.0 cm (Group A)
• The diameter is > 5.5 cm and the patient is unfit for operation or refuses intervention (Group B)
• Follow-up with ultrasound should be possible (obesity)

Exclusion Criteria

• Unable to comply with follow-up
• Contra indications for doxycycline (excessive sun exposure)
• Known impaired liver function (ALAT >3-fold normal values) or known kidney dysfunction (estimate clearance less than 40 ml/min)
• Excessive sun exposure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Aneurysm progression at t=18 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Seconday outcome measures are growth at 6 and 12 months, need for elective<br /><br>aneurysm repair, rupture, death, and an inventory of possible side-effects<br /><br>(questionnaire). Moreover, possible beneficial effects of doxycycline therapy<br /><br>on the progression of atherosclerosis and emphysema will be evaluated by<br /><br>assessment of intima media thickness (carotid artery), plasma inflammatory<br /><br>markers (CRP, fibrinogen) and endothelial cell markers (sICAM, von Willebrand<br /><br>factor), and spirometric testing (FEV1, FVC, FEV1/FVC, VC). </p><br>