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High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

ConditionsMechanical ThrombectomyAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhongda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Atorvastatin 20mg

    Drug

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

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: high-dose armActive comparator 1 intervention
Group B: standard-dose armOther 1 intervention

Trial outcomes

Primary outcomes

1

Cerebral vascular wall damage

Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI

Time frame
within 5-7 days after MT

Secondary outcomes

1

Target vessel stenosis rate

The stenosis rate of target blood vessel artery 5-7 days after MT surgery.

Time frame
Within 5-7 days after MT
2

Perioperative complications

Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.

Time frame
Within 30 days after MT
3

Neurological function evaluation

Proportion of patients with good prognosis 3 months after MT surgery.

Time frame
Within 90 days after MT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongda Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: