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High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

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ClinicalTrials.gov Identifier: NCT05912686
Recruitment Status : Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Thrombectomy Acute Ischemic Stroke Drug: Atorvastatin 80mg Drug: Atorvastatin 20mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: high-dose arm
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.
 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.
standard-dose arm
a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy
 Drug: Atorvastatin 20mg
The control group will receive a consistent standard dose (20mg/day) of atorvastatin.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05912686


Contacts
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Contact: Gao-Jun Teng, M.D. +86-02583272121 gjteng@vip.sina.com

Locations
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China, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Gao-Jun Teng, M.D. Zhongda hospital, Southeast university, Nanjing, China
Principal Investigator: Hai-Peng Wang, M.D. Zhongda hospital, Southeast university, Nanjing, China
More Information
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Publications:

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Responsible Party: Gao-jun Teng, Dean, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT05912686    
Other Study ID Numbers: PVD-MT
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors