High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting

Study Overview
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Brief Summary
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The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in Chinese patients undergoing CAS.

Detailed Description
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Chinese patients with carotid stenosis scheduled for selective CAS will be randomized into two groups. The High-dose Atorvastatin group will receive Atorvastatin 80 mg QD from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS, while the Conventional-dose Atorvastatin group will receive Atorvastatin 20 mg QD from 3 days before to 30 days after CAS. All patients will receive cerebral diffusion-weighted (DW)-MRI within 7 days before CAS. Then, they will also receive repeated DW-MRI within 5 days after CAS. Efficacy for prevention of periprocedural ischemic brain damage of the two different Atorvastatin treatments will be compared, in terms of periprocedural incidence of transient ischemic attack (TIA)/ ischaemic stroke or new ischemic lesions on cerebral DW-MRI.

Official Title
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Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Drug: High-dose Atorvastatin
* Drug: Conventional-dose Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 50% stenosis of internal carotid artery in symptomatic patients; or ≥ 70% stenosis of internal carotid artery in asymptomatic patients received statin therapy for ≥ 2weeks before inclusion Exclusion Criteria: nonatherosclerotic carotid disease (dissection, radiation-induced stenosis) received endovascular procedure within 30 days before inclusion CAS during the procedure of urgent endovascular therapy for acute ischaemic stroke need for oral anticoagulant therapy high risk of bleeding or contraindications to antiplatelet therapy (eg: platelet count <70 X 109/L) active hepatic disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 upper normal limit myopathy or increased creatine kinase (CK) > 2 upper normal limit renal failure with serum creatinine (Scr) > 3 mg/dl or 264μmol/L unable to undergo MRI because of claustrophobia or pacemaker pregnancy, lactation, or child bearing potential women without any effective contraception

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-dose Atorvastatin Arm<br>High dose Atorvastatin (80 mg QD from 3 days before to 3 days after carotid artery stenting, thereafter conventional dose of Atorvastatin with 20mg QD until 30 days after CAS) | Drug: High-dose Atorvastatin<br>* high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)<br>* Other names: Lipitor;|
| Other: Conventional-dose Atorvastatin Arm<br>Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS) | Drug: Conventional-dose Atorvastatin<br>* conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain damage | composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemic brain damage-1 | incidence of new ischemic lesion on post-CAS DW-MRI | within 5 days | 
| ischemic brain damage-2 | number of new lesions on post-CAS DW-MRI | within 5 days | 
| ischemic brain damage-3 | incidence of new lesion > 5 mm on post-CAS DW-MRI | within 5 days | 
| ischemic brain damage-4 | composite incidence of TIA or ischaemic stroke within 30 days after CAS | 30 days | 
| death, any stroke, or myocardial infarction | composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atorvastatin