ROSuvastatin Pretreatment during Carotid Artery Stenting

• Conditions: MedDRA version: 14.1Level: PTClassification code 10007687Term: Carotid artery stenosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Asymptomatic carotid stenosis >80% in patients with baseline LDL cholesterol >120 mg/dL.

• Registration Number: EUCTR2009-016737-95-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-06
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <5 years; contraindication to aspirin or thienopyridines; severe renal dysfunction precluding safe contrast medium administration). - Baseline LDL >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

- Baseline LDL =120 mg/dL and CRP level = 4 mg/dL. - Impossibility to use embolic protection. - Recent (<3 months) neurologic symptoms (cerebral or ocular ischemia ipsilateral to the carotid stenosis to be treated with CAS) requiring intervention on the carotid artery without delay. - Treatment with any statin within 6 months before the time of screening;- Active internal bleeding. - Recent cranial or spinal trauma or surgery (within 2 months). - Recent gastroenteric or genitourinary bleeding (within 6 weeks) of clinical significance. - Haemorrhagic diathesis- - Thrombocitopenia (<100.000 PLT/ml). - Severe uncontrolled arterial hypertension. - Intracranial neoplasm or arteriovenous malformation or aneurysm. - Contraindication to aspirin and/or thienopyridines. -Pregnancy and lactation. - Women in fertile age or women who do not satisfy the following definition of postmenopause: physiological amenorrhoea dating >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified