Back to resultsHigh-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
Primary Purpose
Mechanical Thrombectomy, Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Atorvastatin 80mg
Atorvastatin 20mg
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Thrombectomy
Eligibility Criteria
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
Sites / Locations
- Zhongda Hospital, Southeast University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
high-dose arm
standard-dose arm
Arm 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.
a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy
Outcomes
Primary Outcome Measures
Cerebral vascular wall damage
Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI
Secondary Outcome Measures
Target vessel stenosis rate
The stenosis rate of target blood vessel artery 5-7 days after MT surgery.
Perioperative complications
Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.
Neurological function evaluation
Proportion of patients with good prognosis 3 months after MT surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05912686
Brief Title
High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
Official Title
High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Thrombectomy, Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
162 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-dose arm
Arm Type
Active Comparator
Arm 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.
Arm Title
standard-dose arm
Arm Type
Other
Arm Description
a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Intervention Description
The control group will receive a consistent standard dose (20mg/day) of atorvastatin.
Primary Outcome Measure Information:
Title
Cerebral vascular wall damage
Description
Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI
Time Frame
within 5-7 days after MT
Secondary Outcome Measure Information:
Title
Target vessel stenosis rate
Description
The stenosis rate of target blood vessel artery 5-7 days after MT surgery.
Time Frame
Within 5-7 days after MT
Title
Perioperative complications
Description
Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.
Time Frame
Within 30 days after MT
Title
Neurological function evaluation
Description
Proportion of patients with good prognosis 3 months after MT surgery.
Time Frame
Within 90 days after MT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao-Jun Teng, M.D.
Phone
+86-02583272121
Email
gjteng@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, M.D.
Organizational Affiliation
Zhongda hospital, Southeast university, Nanjing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hai-Peng Wang, M.D.
Organizational Affiliation
Zhongda hospital, Southeast university, Nanjing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28366071
Citation
Abraham P, Scott Pannell J, Santiago-Dieppa DR, Cheung V, Steinberg J, Wali A, Gupta M, Rennert RC, Lee RR, Khalessi AA. Vessel wall signal enhancement on 3-T MRI in acute stroke patients after stent retriever thrombectomy. Neurosurg Focus. 2017 Apr;42(4):E20. doi: 10.3171/2017.1.FOCUS16492.
Results Reference
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PubMed Identifier
29655219
Citation
Perren F, Kargiotis O, Pignat JM, Pereira VM. Hemodynamic Changes May Indicate Vessel Wall Injury After Stent Retrieval Thrombectomy for Acute Stroke. J Neuroimaging. 2018 Jul;28(4):412-415. doi: 10.1111/jon.12513. Epub 2018 Apr 14.
Results Reference
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PubMed Identifier
34785610
Citation
Krishnan R, Mays W, Elijovich L. Complications of Mechanical Thrombectomy in Acute Ischemic Stroke. Neurology. 2021 Nov 16;97(20 Suppl 2):S115-S125. doi: 10.1212/WNL.0000000000012803.
Results Reference
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PubMed Identifier
32139427
Citation
Lindenholz A, van der Schaaf IC, van der Kolk AG, van der Worp HB, Harteveld AA, Kappelle LJ, Hendrikse J. MRI Vessel Wall Imaging after Intra-Arterial Treatment for Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2020 Apr;41(4):624-631. doi: 10.3174/ajnr.A6460. Epub 2020 Mar 5.
Results Reference
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High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
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