Clinical trial NCT05912686: High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
Official title: High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Mechanical Thrombectomy
Acute Ischemic Stroke
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of acute ischemic stroke;
2. With anterior circulation acute stroke who meet and receive emergency endovascular treatment;
3. 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);
4. Recanalization of blood vessels after operation (mTICI ≥ 2b grade)

Exclusion Criteria:

1. Placing permanent stents or other implants in the target artery
2. Can not receive HR-VWI examination of 3T MRI due to claustrophobia or unstable condition
3. Contraindications to MRI and/or intravenous gadolinium

Primary outcomes:
measure: Cerebral vascular wall damage
timeFrame: within 5-7 days after MT
Secondary outcomes:
measure: Target vessel stenosis rate
timeFrame: Within 5-7 days after MT
measure: Perioperative complications
timeFrame: Within 30 days after MT
measure: Neurological function evaluation
timeFrame: Within 90 days after MT
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda hospital, Southeast university, Nanjing, China
name: Gao-Jun Teng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda hospital, Southeast university, Nanjing, China
name: Hai-Peng Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.