MedTrace Logo

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

NCT04328064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-03-31

No results posted yet for this study

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

DRUG

Rosuvastatin calcium 40mg

Active drug -Rosuvastatin

DRUG

Placebo oral tablet

40 mg placebo for 12 months

Sponsors & Collaborators

  • University of Alexandria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328064 on ClinicalTrials.gov