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Pharmaceutical Aneurysm Stabilisation Trial

Doxycycline treatment for the stabilization of abdominal aortic aneurysms (AAA), a randomized placebo controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23083
Enrollment
300
Registered
2008-06-16
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Abdominal aortic aneurysm - Inflammation - Cardiovascular diseases - Metalloproteinases - Doxycycline - Pharmaceutical Treatment

Interventions

Doxycycline 100mg or placebo daily, 18 mo

Sponsors

Nuts Ohra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients under surveillance with small aneurysms (i.e. 3.5-5.0 cm), and in larger AAA in patients who are unfit for or refuse open operation or endovascular intervention of their larger AAA (i.e. exceeding 5.0 cm).

Exclusion criteria

Exclusion criteria: 1. Unable to comply with follow up. 2. Contra-indications for doxycycline: - known impaired liver function (ALAT >3-fold normal values) - known renal failure (estimate clearance below 40 ml/min) - excessive sun exposure.

Design outcomes

Primary

MeasureTime frame
* Aneurysm growth at t=18 months as determined by ultrasound

Secondary

MeasureTime frame
* Secondary outcome measures are: - growth at 6 and 12 months - need for elective aneurysm repair - rupture - death - an inventory of possible side effects (questionnaire). Moreover, posible effect on atherosclerosis will be evaluated by: - assesment of intima media thickness (carotid artery) - plasma inflmmatory markers - endothelial cell markers - spirometric testing.

Contacts

Public ContactJan H. Lindeman

Leiden University Medical Center Dpt. of Vascular Surgery. PO-box 9600

Lindeman@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)