High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

NCT05912686 | Not Yet Recruiting Phase 4

• 1 other identifier: PVD-MT
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Thrombectomy; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Target vessel stenosis rate

  Within 5-7 days after MT

• Perioperative complications

  Within 30 days after MT

• Neurological function evaluation

  Within 90 days after MT

Study Arms (2)

high-dose arm

ACTIVE COMPARATOR

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

standard-dose arm

OTHER

a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy

Drug: Atorvastatin 20mg

Interventions

Atorvastatin 80mg DRUG

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.

high-dose arm

Atorvastatin 20mg DRUG

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

standard-dose arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related 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.

  PMID: 28366071 BACKGROUND

• 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.

  PMID: 29655219 BACKGROUND

• 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.

  PMID: 34785610 BACKGROUND

• 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.

  PMID: 32139427 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Gao-Jun Teng, M.D.

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

• Hai-Peng Wang, M.D.

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, M.D.

CONTACT

+86-02583272121; gjteng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)