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
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
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
NCT ID
NCT04328064
First Posted
August 29, 2011
Last Updated
March 27, 2020
Sponsor
University of Alexandria
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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