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

Primary Purpose

Behcet's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rosuvastatin calcium 40mg
Placebo oral tablet
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Disease focused on measuring Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Rosuvastatin Drug

    Placebo drug

    Arm Description

    Active drug-rosuvastatin 40 mg

    Placebo oral tablet

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Occurrence of new-onset vascular involvement

    Full Information

    First Posted
    August 29, 2011
    Last Updated
    March 27, 2020
    Sponsor
    University of Alexandria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04328064
    Brief Title
    The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alexandria

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behcet's Disease
    Keywords
    Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rosuvastatin Drug
    Arm Type
    Active Comparator
    Arm Description
    Active drug-rosuvastatin 40 mg
    Arm Title
    Placebo drug
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo oral tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin calcium 40mg
    Other Intervention Name(s)
    Experimental active drug
    Intervention Description
    Active drug -Rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral tablet
    Other Intervention Name(s)
    Placebo comparator
    Intervention Description
    40 mg placebo for 12 months
    Primary Outcome Measure Information:
    Title
    Changes in endothelial and vascular inflammatory markers
    Description
    Outcome measures included alterations in endothelial injury and vascular inflammatory markers.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Occurrence of new-onset vascular involvement
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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