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The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04328064
Enrollment
56
Registered
2020-03-31
Start date
2010-05-31
Completion date
2011-06-30
Last updated
2020-03-31

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

Conditions

Behcet's Disease

Keywords

Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease

Brief summary

Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups. The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.

Interventions

Active drug -Rosuvastatin

DRUGPlacebo oral tablet

40 mg placebo for 12 months

Sponsors

University of Alexandria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* all patients fulfilling the classification criteria of the International Study Group for Behçet's disease

Exclusion criteria

* smoking, * diabetes mellitus, * hypercholesterolaemia, * hypertension, * cardiac insufficiency, * coexisting hepatic and renal diseases * inflammatory diseases.

Design outcomes

Primary

MeasureTime frameDescription
Changes in endothelial and vascular inflammatory markers12 monthsOutcome measures included alterations in endothelial injury and vascular inflammatory markers.

Secondary

MeasureTime frame
Occurrence of new-onset vascular involvement6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026