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

Primary Purpose

Carotid Artery Stenosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
High-dose Atorvastatin
Conventional-dose Atorvastatin
Sponsored by
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Atorvastatin

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

High-dose Atorvastatin Arm

Conventional-dose Atorvastatin Arm

Arm Description

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)

Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2017
Last Updated
April 8, 2020
Sponsor
Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03079115
Brief Title
High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting
Acronym
PICAS
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose Atorvastatin Arm
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Conventional-dose Atorvastatin Arm
Arm Type
Other
Arm Description
Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)
Intervention Type
Drug
Intervention Name(s)
High-dose Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)
Intervention Type
Drug
Intervention Name(s)
Conventional-dose Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
Primary Outcome Measure Information:
Title
brain damage
Description
composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ischemic brain damage-1
Description
incidence of new ischemic lesion on post-CAS DW-MRI
Time Frame
within 5 days
Title
ischemic brain damage-2
Description
number of new lesions on post-CAS DW-MRI
Time Frame
within 5 days
Title
ischemic brain damage-3
Description
incidence of new lesion > 5 mm on post-CAS DW-MRI
Time Frame
within 5 days
Title
ischemic brain damage-4
Description
composite incidence of TIA or ischaemic stroke within 30 days after CAS
Time Frame
30 days
Title
death, any stroke, or myocardial infarction
Description
composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Lu, M.D.
Phone
+86 10 85136282
Email
frente.lu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang
Phone
+86 10 58115037
Email
wangxinannie@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Lu, M.D.
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang
Phone
+8613661174001
Email
wangxinannie@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32982944
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.
Results Reference
derived

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

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