Asymptomatic carotid stenosis >80% in patients with baseline LDL cholesterol >120 mg/dL. MedDRA version: 14.1 Level: PT Classification code 10007687 Term: Carotid artery stenosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Carotid stenosis =80% at ultrasound in asymptomatic patients; - Male and female; - Age between 18 and 80 years; - No contraindications to CAS (major functional or cognitive impairment; inability to achieve safe vascular access; extreme carotid lesion calcification; visible thrombus in lesion; long subtotal occlusion (string sign); life expectancy 120 mg/dL and/or baseline CRP level > 4 mg/dL. -Informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: - Baseline LDL =120 mg/dL and CRP level = 4 mg/dL. - Impossibility to use embolic protection. - Recent (12 months or bilateral ovariectomy dating > 6 weeks (in the case of single ovariectomy the reproductive state must be assessed by hormonal determination). -Hypersensitivity to rosuvastatin or to any of the excipients. - Active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN). Moderate to severe renal impairment (creatinine clearance <60 ml/min). - Myopathy. - Concomitant use of ciclosporin, fibrates, or vitamin K antagonists. - Hypothyroidism. - Personal or family history of hereditary muscular disorders. - Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate. - Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the administration of rosuvastatin 40 mg o.d. for 6 weeks before elective carotid artery stenting in hypercholesterolemic patients reduces the extent of distal embolization during the procedure.;Secondary Objective: a)To demonstrate that the administration of rosuvastatin 40 mg o.d. for 6 weeks before elective carotid reduces the rate of peri-procedural and 30-day cerebral ischaemic complications (TIA, minor/major stroke, death). b)To demonstrate that the administration of rosuvastatin 40 mg o.d. for 6 weeks modifies the histopathology of embolic debris, by reducing the inflammatory and lipidic components. c)To demonstrate that the administration of rosuvastatin 40 mg o.d. for 6 weeks reduces the circulating levels of inflammatory markers including CRP, interleukin-6, interleukin-18, sLOX-1, sRAGE.;Primary end point(s): Extent of carotid plaque embolization during the procedure, assessed by visual inspection of the embolic protection filter by a single, expert pathologist, and quantified as scarce embolization (no visible debris or hardly visible debris), or relevant embolization (visible debris in the filter).;Timepoint(s) of evaluation of this end point: Embolization assessment will be performed immediately after CAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prevalence of death and cerebral ischaemic complication (TIA, minor/major stroke).;Timepoint(s) of evaluation of this end point: Prevalence of death and cerebral ischaemic complication (TIA, minor/major stroke) during CAS and at 30 days, 6 months and 1 year. | — |
Countries
Italy
Contacts
Public ContactU.O. Malattie Cardiovascolari I
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Outcome results
None listed