High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05912686
• Other study ID #: PVD-MT
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2023
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng, M.D.
• Phone: +86-02583272121
• Email: gjteng[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: July 31, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Mechanical Thrombectomy

Intervention

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.
• Atorvastatin 20mg
The control group will receive a consistent standard dose (20mg/day) of atorvastatin.

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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