High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

Southeast University

Status and phase: Not yet enrolling; Phase 4

Conditions: Mechanical Thrombectomy; Acute Ischemic Stroke

Treatments: Drug: Atorvastatin 80mg; Drug: Atorvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05912686

PVD-MT

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

high-dose arm

Active Comparator group

Description:

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.

Treatment:

Drug: Atorvastatin 80mg

standard-dose arm

Other group

Description:

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

Treatment:

Drug: Atorvastatin 20mg