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

NCT ID: NCT04328064

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Behcet's Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rosuvastatin Drug

Active drug-rosuvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin calcium 40mg

Intervention Type DRUG

Active drug -Rosuvastatin

Placebo oral tablet

Intervention Type DRUG

40 mg placebo for 12 months

Placebo drug

Placebo oral tablet

Group Type PLACEBO_COMPARATOR

Rosuvastatin calcium 40mg

Intervention Type DRUG

Active drug -Rosuvastatin

Placebo oral tablet

Intervention Type DRUG

40 mg placebo for 12 months

Interventions

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Rosuvastatin calcium 40mg

Active drug -Rosuvastatin

Intervention Type DRUG

Placebo oral tablet

40 mg placebo for 12 months

Intervention Type DRUG

Other Intervention Names

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Experimental active drug Placebo comparator

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Anna Abou-Raya

Professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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alexmed116619312

Identifier Type: -

Identifier Source: org_study_id