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临床试验/NCT04328064
NCT04328064已完成不适用

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

University of Alexandria0 个研究点目标入组 56 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
56
主要终点
Changes in endothelial and vascular inflammatory markers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients fulfilling the classification criteria of the International Study Group for Behçet's disease

排除标准

  • diabetes mellitus,
  • hypercholesterolaemia,
  • hypertension,
  • cardiac insufficiency,
  • coexisting hepatic and renal diseases
  • inflammatory diseases.

研究组 & 干预措施

Rosuvastatin Drug

Active Comparator

Active drug-rosuvastatin 40 mg

干预措施: Rosuvastatin calcium 40mg (Drug)

Rosuvastatin Drug

Active Comparator

Active drug-rosuvastatin 40 mg

干预措施: Placebo oral tablet (Drug)

Placebo drug

Placebo Comparator

Placebo oral tablet

干预措施: Rosuvastatin calcium 40mg (Drug)

Placebo drug

Placebo Comparator

Placebo oral tablet

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

Changes in endothelial and vascular inflammatory markers

时间窗: 12 months

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

次要结局

  • Occurrence of new-onset vascular involvement(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Abou-Raya

Professor of Rheumatology

University of Alexandria

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