Clinical trial NCT03079115: High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting
Official title: Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carotid Artery Stenosis
Keywords: Atorvastatin
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2017-03-14
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: brain damage
timeFrame: 30 days
Secondary outcomes:
measure: ischemic brain damage-1
timeFrame: within 5 days
measure: ischemic brain damage-2
timeFrame: within 5 days
measure: ischemic brain damage-3
timeFrame: within 5 days
measure: ischemic brain damage-4
timeFrame: 30 days
measure: death, any stroke, or myocardial infarction
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Jun Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Wang J, Lu J, Wang D. Effects of High Dose of Atorvastatin for Preventing Periprocedural Ischemic Brain Damage in Patients Undergoing Carotid Artery Stenting (PICAS) in China: A Randomized Controlled Clinical Trial. Front Neurol. 2020 Aug 25;11:937. doi: 10.3389/fneur.2020.00937. eCollection 2020.