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)
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedApril 9, 2020
April 1, 2020
2.7 years
March 6, 2017
April 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
ischemic brain damage-1
within 5 days
ischemic brain damage-2
within 5 days
ischemic brain damage-3
within 5 days
ischemic brain damage-4
30 days
death, any stroke, or myocardial infarction
30 days
Study Arms (2)
High-dose Atorvastatin Arm
ACTIVE COMPARATORHigh 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)
Conventional-dose Atorvastatin Arm
OTHERConventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)
Interventions
high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
Eligibility Criteria
You may qualify if:
- ≥ 50% stenosis of internal carotid artery in symptomatic patients; or ≥ 70% stenosis of internal carotid artery in asymptomatic patients
You may not qualify if:
- nonatherosclerotic carotid disease (dissection, radiation-induced stenosis)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Hospitallead
Study Sites (1)
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (2)
Wang H, Wang J, Qi P, Yang X, Chen K, Hu S, Liu E, Zhang S, Gao Q, Li R, Lu J, Deng G, Wang D. A single-center pilot randomized controlled trial of atorvastatin loading for preventing ischemic brain damage after carotid artery stenting. Front Aging Neurosci. 2022 Dec 23;14:1066316. doi: 10.3389/fnagi.2022.1066316. eCollection 2022.
PMID: 36620770DERIVEDWang 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.
PMID: 32982944DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Lu, M.D.
Beijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician; MD
Study Record Dates
First Submitted
March 6, 2017
First Posted
March 14, 2017
Study Start
August 21, 2017
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
April 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share