High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: high-dose arm 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
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.
|
| Other: standard-dose arm a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy |
Drug: Atorvastatin 20mg
The control group will receive a consistent standard dose (20mg/day) of atorvastatin.
|
Outcome Measures
Primary Outcome Measures
- Cerebral vascular wall damage [within 5-7 days after MT]
Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI
Secondary Outcome Measures
- Target vessel stenosis rate [Within 5-7 days after MT]
The stenosis rate of target blood vessel artery 5-7 days after MT surgery.
- Perioperative complications [Within 30 days after MT]
Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.
- Neurological function evaluation [Within 90 days after MT]
Proportion of patients with good prognosis 3 months after MT surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of acute ischemic stroke;
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With anterior circulation acute stroke who meet and receive emergency endovascular treatment;
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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);
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Recanalization of blood vessels after operation (mTICI ≥ 2b grade)
Exclusion Criteria:
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Placing permanent stents or other implants in the target artery
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Can not receive HR-VWI examination of 3T MRI due to claustrophobia or unstable condition
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Contraindications to MRI and/or intravenous gadolinium
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongda Hospital, Southeast University | Nanjing | Jiangsu | China | 210009 |
Sponsors and Collaborators
- Zhongda Hospital
Investigators
- Principal Investigator: Gao-Jun Teng, M.D., Zhongda hospital, Southeast university, Nanjing, China
- Principal Investigator: Hai-Peng Wang, M.D., Zhongda hospital, Southeast university, Nanjing, China
Study Documents (Full-Text)
None provided.More Information
Publications
- Abraham P, Scott Pannell J, Santiago-Dieppa DR, Cheung V, Steinberg J, Wali A, Gupta M, Rennert RC, Lee RR, Khalessi AA. Vessel wall signal enhancement on 3-T MRI in acute stroke patients after stent retriever thrombectomy. Neurosurg Focus. 2017 Apr;42(4):E20. doi: 10.3171/2017.1.FOCUS16492.
- Krishnan R, Mays W, Elijovich L. Complications of Mechanical Thrombectomy in Acute Ischemic Stroke. Neurology. 2021 Nov 16;97(20 Suppl 2):S115-S125. doi: 10.1212/WNL.0000000000012803.
- Lindenholz A, van der Schaaf IC, van der Kolk AG, van der Worp HB, Harteveld AA, Kappelle LJ, Hendrikse J. MRI Vessel Wall Imaging after Intra-Arterial Treatment for Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2020 Apr;41(4):624-631. doi: 10.3174/ajnr.A6460. Epub 2020 Mar 5.
- Perren F, Kargiotis O, Pignat JM, Pereira VM. Hemodynamic Changes May Indicate Vessel Wall Injury After Stent Retrieval Thrombectomy for Acute Stroke. J Neuroimaging. 2018 Jul;28(4):412-415. doi: 10.1111/jon.12513. Epub 2018 Apr 14.
- PVD-MT