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

Sponsor

University of Alexandria (Other)

Overall Status

Completed

CT.gov ID

NCT04328064

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Behcet's Disease	Drug: Rosuvastatin calcium 40mg Drug: Placebo oral tablet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rosuvastatin Drug Active drug-rosuvastatin 40 mg	Drug: Rosuvastatin calcium 40mg Active drug -Rosuvastatin Other Names: Experimental active drug Drug: Placebo oral tablet 40 mg placebo for 12 months Other Names: Placebo comparator
Placebo Comparator: Placebo drug Placebo oral tablet	Drug: Rosuvastatin calcium 40mg Active drug -Rosuvastatin Other Names: Experimental active drug Drug: Placebo oral tablet 40 mg placebo for 12 months Other Names: Placebo comparator

Arm

Intervention/Treatment

Active Comparator: Rosuvastatin Drug

Active drug-rosuvastatin 40 mg

Drug: Rosuvastatin calcium 40mg

Active drug -Rosuvastatin

Other Names:

Experimental active drug

Drug: Placebo oral tablet

40 mg placebo for 12 months

Other Names:

Placebo comparator

Placebo Comparator: Placebo drug

Placebo oral tablet

Drug: Rosuvastatin calcium 40mg

Active drug -Rosuvastatin

Other Names:

Experimental active drug

Drug: Placebo oral tablet

40 mg placebo for 12 months

Other Names:

Placebo comparator

Outcome Measures

Primary Outcome Measures

Changes in endothelial and vascular inflammatory markers [12 months]
Outcome measures included alterations in endothelial injury and vascular inflammatory markers.

Secondary Outcome Measures

Occurrence of new-onset vascular involvement [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alexandria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Abou-Raya, Professor of Rheumatology, University of Alexandria

ClinicalTrials.gov Identifier:

NCT04328064

Other Study ID Numbers:

alexmed116619312

First Posted:

Mar 31, 2020

Last Update Posted:

Mar 31, 2020

Last Verified:

Mar 1, 2020

Keywords provided by Anna Abou-Raya, Professor of Rheumatology, University of Alexandria

Behcet's Disease

Rosuvastatin

Vascular Markers

Improvement in vascular involvement in Behcet's Disease

Additional relevant MeSH terms:

Behcet Syndrome

Rosuvastatin Calcium

Calcium

Study Results

No Results Posted as of Mar 31, 2020