Carotid Artery Stenosis Clinical Trial
— PICASOfficial title:
Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ischemic brain damage-1 | incidence of new ischemic lesion on post-CAS DW-MRI | within 5 days | |
Secondary | ischemic brain damage-2 | number of new lesions on post-CAS DW-MRI | within 5 days | |
Secondary | ischemic brain damage-3 | incidence of new lesion > 5 mm on post-CAS DW-MRI | within 5 days | |
Secondary | ischemic brain damage-4 | composite incidence of TIA or ischaemic stroke within 30 days after CAS | 30 days | |
Secondary | death, any stroke, or myocardial infarction | composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS | 30 days |
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