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NCT Number: NCT05912686

High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

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.

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Key information

Conditions

Mechanical Thrombectomy Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Cerebral vascular wall damage

    Time frame: within 5-7 days after MT

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

Secondary outcomes

  1. Target vessel stenosis rate

    Time frame: Within 5-7 days after MT

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

  2. Perioperative complications

    Time frame: Within 30 days after MT

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

  3. Neurological function evaluation

    Time frame: Within 90 days after MT

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gao-Jun Teng, M.D.

CONTACT

[email protected]

+86-02583272121

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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