NCT04328064

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Alexandria · Academic / Other
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Behcet's Disease

Interventions

Type	Name	Description
DRUG	Rosuvastatin calcium 40mg	Active drug -Rosuvastatin
DRUG	Placebo oral tablet	40 mg placebo for 12 months

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2020-03-31
• Last updated: 2020-03-31