Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912686
Enrollment
162
Registered
2023-06-22
Start date
2023-07-01
Completion date
2026-07-31
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Mechanical Thrombectomy

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.

Interventions

DRUGAtorvastatin 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.

DRUGAtorvastatin 20mg

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

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Single (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral vascular wall damagewithin 5-7 days after MTIncidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI

Secondary

MeasureTime frameDescription
Target vessel stenosis rateWithin 5-7 days after MTThe stenosis rate of target blood vessel artery 5-7 days after MT surgery.
Perioperative complicationsWithin 30 days after MTCumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.
Neurological function evaluationWithin 90 days after MTProportion of patients with good prognosis 3 months after MT surgery.

Countries

China

Contacts

Primary ContactGao-Jun Teng, M.D.
gjteng@vip.sina.com+86-02583272121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026