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

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.

Study Overview

• Status: Unknown
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Drug: High-dose Atorvastatin; Drug: Conventional-dose Atorvastatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High-dose Atorvastatin Arm; 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; high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS); Other Names: Lipitor
Other: Conventional-dose Atorvastatin Arm; Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)	Drug: Conventional-dose Atorvastatin; conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).; Other Names: Lipitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Principal Investigator: Jun Lu, M.D., Beijing Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Atorvastatin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Carotid Artery Diseases; Brain Injuries; Carotid Stenosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 121-2016006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No