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

NCT04328064 | Completed DMC

• 1 other identifier: alexmed116619312
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Behcet's Disease

Keywords

Behcet's Disease; Rosuvastatin; Vascular Markers; Improvement in vascular involvement in Behcet's Disease

Outcome Measures

Primary Outcomes (1)

• Changes in endothelial and vascular inflammatory markers

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

  12 months

Secondary Outcomes (1)

• Occurrence of new-onset vascular involvement

  6 months

Study Arms (2)

Rosuvastatin Drug

ACTIVE COMPARATOR

Active drug-rosuvastatin 40 mg

Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet

Placebo drug

PLACEBO COMPARATOR

Placebo oral tablet

Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet

Interventions

Rosuvastatin calcium 40mg DRUG

Active drug -Rosuvastatin

Also known as: Experimental active drug

Placebo drug; Rosuvastatin Drug

Placebo oral tablet DRUG

40 mg placebo for 12 months

Also known as: Placebo comparator

Placebo drug; Rosuvastatin Drug

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alexandria: lead

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: March 31, 2020
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 31, 2020

Record last verified: 2020-03