NCT05912686

High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Atorvastatin 20mg	The control group will receive a consistent standard dose (20mg/day) of atorvastatin.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-01
• Completion: 2026-07-31
• First posted: 2023-06-22
• Last updated: 2023-06-23

Locations

1 site across 1 country: China