High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

Phase 4

Not yet recruiting

• Conditions: Mechanical Thrombectomy; Acute Ischemic Stroke
• Interventions: Drug: Atorvastatin 20mg; Drug: Atorvastatin 80mg

• Registration Number: NCT05912686
• Lead Sponsor: Zhongda Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-11
• Study First Submitted QC: 2023-06-11
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-23
• Study Start: 2023-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard-dose arm	Atorvastatin 20mg	a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy
high-dose arm	Atorvastatin 80mg	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China