High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

Study Overview
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Brief Summary
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This project investigates the impact of statins on cerebral vascular wall damage after mechanical thrombectomy. The investigators will undertake a multi-center, prospective, parallel-controlled, open-label, superiority randomized controlled study based on past research on intense lipid-lowering intervention trials. Patients undergoing post-thrombectomy will be divided into two groups: the test group and the control group. After surgery, the test group will be given a high dose of atorvastatin (80mg/day), followed by a standard dose (20mg/day). The control group will continue to receive the standard dose of atorvastatin (20mg/day). The investigators will compare the high-resolution vascular wall MRI characteristics (vascular wall enhancement, lumen stenosis rate, and so on) within 3-5 days of the operation, as well as the composite incidence of ischemic stroke, transient ischemic attack, intracranial hemorrhage 1 month postoperatively, and the modified Rankin Score at 90 days.

Official Title
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High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy

Conditions
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Mechanical Thrombectomy, Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Atorvastatin 80mg
* Drug: Atorvastatin 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acute ischemic stroke; With anterior circulation acute stroke who meet and receive emergency endovascular treatment; CTA or DSA confirms anterior circulation intracranial arterial lesions, including MT of intracranial arteries (middle cerebral artery (MCA), internal carotid artery (ICA), basilar artery and/or vertebral artery and P1 segment of posterior cerebral artery (PCA); Recanalization of blood vessels after operation (mTICI ≥ 2b grade) Exclusion Criteria: Placing permanent stents or other implants in the target artery Can not receive HR-VWI examination of 3T MRI due to claustrophobia or unstable condition Contraindications to MRI and/or intravenous gadolinium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high-dose arm<br>The test group will undergo high-dose atorvastatin treatment (80mg/day) for the first 3 days after the mechanical embolectomy, transitioning to a standard dose (20mg/day) of atorvastatin thereafter. | Drug: Atorvastatin 80mg<br>* The test group will undergo high-dose atorvastatin treatment (80mg/day) for the first 3 days after the procedure, transitioning to a standard dose (20mg/day) of atorvastatin thereafter.<br>|
| Other: standard-dose arm<br>a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy | Drug: Atorvastatin 20mg<br>* The control group will receive a consistent standard dose (20mg/day) of atorvastatin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral vascular wall damage | Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI | within 5-7 days after MT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel stenosis rate | The stenosis rate of target blood vessel artery 5-7 days after MT surgery. | Within 5-7 days after MT | 
| Perioperative complications | Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery. | Within 30 days after MT | 
| Neurological function evaluation | Proportion of patients with good prognosis 3 months after MT surgery. | Within 90 days after MT |