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OpenTrials
Completed

NCT Number: NCT04328064

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin calcium 40mg

Drug

Active drug -Rosuvastatin

Other names: Experimental active drug

Placebo oral tablet

Drug

40 mg placebo for 12 months

Other names: Placebo comparator

Primary outcomes

  1. Changes in endothelial and vascular inflammatory markers

    Time frame: 12 months

    Outcome measures included alterations in endothelial injury and vascular inflammatory markers.

Secondary outcomes

  1. Occurrence of new-onset vascular involvement

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2020
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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