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

Behcet's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328064
• Other study ID #: alexmed116619312
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease

Intervention

Drug:
• Rosuvastatin calcium 40mg
Active drug -Rosuvastatin
• Placebo oral tablet
40 mg placebo for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in endothelial and vascular inflammatory markers	Outcome measures included alterations in endothelial injury and vascular inflammatory markers.	12 months
Secondary	Occurrence of new-onset vascular involvement		6 months