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Doxycycline for Stabilization of Abdominal Aortic Aneurysms

Doxycycline for Stabilization of Abdominal Aortic Aneurysms - Doxy-study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31047
Enrollment
300
Registered
2007-07-26
Start date
2008-11-10
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abdominal aortic aneurysm

Interventions

doxycyline 100 mg

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Aneurysm progression at t=18 months

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)