Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Conventional-dose Atorvastatin Arm | Other | Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Atorvastatin | Drug | high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS) |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Lu, M.D. | Contact | +86 10 85136282 | frente.lu@hotmail.com | |
| Xin Wang | Contact | +86 10 58115037 | wangxinannie@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Lu, M.D. | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36620770 | Derived | 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. | |
| 32982944 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional-dose Atorvastatin | Drug | conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS). |
|
|
| 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 |
| 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. |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |