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Not yet recruitingNCT05912686Updated Jun 23, 2023

High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients

A Phase 4 interventional study of Atorvastatin 80mg and Atorvastatin 20mg in Mechanical Thrombectomy and Acute Ischemic Stroke, sponsored by Zhongda Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Zhongda Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Mechanical Thrombectomy
  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 162 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
162 participants (estimated)

Study arms

  • 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

  • Other
    standard-dose arm

    a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy

    Drug: Atorvastatin 20mg

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.

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What researchers measure

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

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Study locations

1 site
  • Zhongda Hospital, Southeast University
    Nanjing, Jiangsu 210009, China
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References and documents

Publications

  • 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. PubMed 28366071 ↗
  • 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. PubMed 29655219 ↗
  • 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. PubMed 34785610 ↗
  • 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. PubMed 32139427 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05912686
Lead sponsor
Zhongda Hospital
Responsible party
Gao-jun Teng (Dean, Zhongda Hospital) — Principal investigator
First posted
Jun 22, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jun 23, 2023

Study contacts

Gao-Jun Teng, M.D.
Contact
gjteng@vip.sina.com
+86-02583272121
Gao-Jun Teng, M.D.
principal investigator · Zhongda hospital, Southeast university, Nanjing, China
Hai-Peng Wang, M.D.
principal investigator · Zhongda hospital, Southeast university, Nanjing, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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