Carotid Artery StenosisPhase 4PICASNCT03079115
High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting
A Phase 4 study testing High-dose Atorvastatin and Conventional-dose Atorvastatin in people with Carotid Artery Stenosis, run by Beijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- High-dose Atorvastatin and Conventional-dose Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to 30 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Xin Wang, +8613661174001, wangxinannie@126.com
About this study
Official 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.
Read the 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.
- Conditions
- Carotid Artery Stenosis
- Being tested
- High-dose Atorvastatin, Conventional-dose Atorvastatin
- Keywords
- Atorvastatin
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose AtorvastatinDrug
Also called Lipitor
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 AtorvastatinDrug
Also called Lipitor
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
| Study group | Role | What they receive |
|---|---|---|
| High-dose Atorvastatin Arm | Active comparator | 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) Receives: Drug: High-dose Atorvastatin |
| Conventional-dose Atorvastatin Arm | Other | Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS) Receives: Drug: Conventional-dose Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain damage
composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
Measured: 30 days
Secondary outcomes (5)
ischemic brain damage-1
incidence of new ischemic lesion on post-CAS DW-MRI
Measured: within 5 days
ischemic brain damage-2
number of new lesions on post-CAS DW-MRI
Measured: within 5 days
ischemic brain damage-3
incidence of new lesion > 5 mm on post-CAS DW-MRI
Measured: within 5 days
ischemic brain damage-4
composite incidence of TIA or ischaemic stroke within 30 days after CAS
Measured: 30 days
death, any stroke, or myocardial infarction
composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start21 Aug 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Lu, Beijing Hospital
- Investigators
- Jun Lu, M.D., Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079115
- Sponsor's protocol ID
- 121-2016006
- Acronym
- PICAS
- Status last verified
- Apr 2020
- First submitted
- 6 Mar 2017
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36620770Wang 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.
PubMed 32982944
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)
- ClinicalTrials.gov ID
- NCT03079115
- Acronym / sponsor ID
- PICAS / 121-2016006
- Conditions
- Carotid Artery Stenosis
- Keywords
- Atorvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose Atorvastatin Arm | Active comparator | Drug: High-dose AtorvastatinHigh 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 | Other | Drug: Conventional-dose AtorvastatinConventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose AtorvastatinAlso: Lipitorhigh-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS) | Drug | High-dose Atorvastatin Arm |
| Conventional-dose AtorvastatinAlso: Lipitorconventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS). | Drug | Conventional-dose Atorvastatin Arm |
Primary outcome
brain damage
Time frame: 30 days
composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS
5 secondary outcomes
ischemic brain damage-1
Time frame: within 5 days
ischemic brain damage-2
Time frame: within 5 days
ischemic brain damage-3
Time frame: within 5 days
ischemic brain damage-4
Time frame: 30 days
death, any stroke, or myocardial infarction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 36620770Wang 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.
- Derived from this study: PubMed 32982944Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Lu, M.D. principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-dose Atorvastatin and Conventional-dose Atorvastatin in people with Carotid Artery Stenosis, run by Beijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Lu, M.D. (+86 10 85136282, frente.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain damage (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.