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

Not Applicable

Completed

• Conditions: Behcet's Disease
• Interventions: Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet

• Registration Number: NCT04328064
• Lead Sponsor: University of Alexandria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Study First Submitted: 2011-08-29
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo drug	Placebo oral tablet	Placebo oral tablet
Rosuvastatin Drug	Rosuvastatin calcium 40mg	Active drug-rosuvastatin 40 mg
Rosuvastatin Drug	Placebo oral tablet	Active drug-rosuvastatin 40 mg
Placebo drug	Rosuvastatin calcium 40mg	Placebo oral tablet

Primary Outcome Measures

Name	Time	Method
Changes in endothelial and vascular inflammatory markers	12 months	Outcome measures included alterations in endothelial injury and vascular inflammatory markers.

Secondary Outcome Measures

Name	Time	Method
Occurrence of new-onset vascular involvement	6 months