Mechanical ThrombectomyPhase 4NCT05912686
High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
A Phase 4 study testing Atorvastatin 80mg and Atorvastatin 20mg in people with Mechanical Thrombectomy and Acute Ischemic Stroke, run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Thrombectomy, Acute Ischemic Stroke
- What is being tested?
- Atorvastatin 80mg and Atorvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
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.
- Conditions
- Mechanical Thrombectomy, Acute Ischemic Stroke
- Being tested
- Atorvastatin 80mg, Atorvastatin 20mg
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
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 20mgDrug
The control group will receive a consistent standard dose (20mg/day) of atorvastatin.
| Study group | Role | What they receive |
|---|---|---|
| high-dose arm | Active comparator | 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. Receives: Drug: Atorvastatin 80mg |
| standard-dose arm | Other | a standard dose (20mg/day) of atorvastatin after the mechanical embolectomy Receives: Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral vascular wall damage
Incidence of T1 hyperintensity and T1 shortening within the arterial wall in HR-VWI
Measured: within 5-7 days after MT
Secondary outcomes (3)
Target vessel stenosis rate
The stenosis rate of target blood vessel artery 5-7 days after MT surgery.
Measured: Within 5-7 days after MT
Perioperative complications
Cumulative incidence rate of symptomatic intracranial hemorrhage, TIA or ischemic stroke within 30 days after MT surgery.
Measured: Within 30 days after MT
Neurological function evaluation
Proportion of patients with good prognosis 3 months after MT surgery.
Measured: Within 90 days after MT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mechanical ThrombectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, M.D., Principal investigator, Zhongda hospital, Southeast university, Nanjing, ChinaHai-Peng Wang, M.D., Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912686
- Sponsor's protocol ID
- PVD-MT
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28366071Perren 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 29655219Krishnan 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 34785610Lindenholz 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose of Atorvastatin for Preventing Cerebral Vascular Wall Damage in Patients Undergoing Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT05912686
- Acronym / sponsor ID
- PVD-MT
- Conditions
- Mechanical Thrombectomy, Acute Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-dose arm | Active comparator | Drug: Atorvastatin 80mgThe 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. |
| standard-dose arm | Other | Drug: Atorvastatin 20mga standard dose (20mg/day) of atorvastatin after the mechanical embolectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80mgThe 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. | Drug | high-dose arm |
| Atorvastatin 20mgThe control group will receive a consistent standard dose (20mg/day) of atorvastatin. | Drug | standard-dose arm |
Primary outcome
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
3 secondary outcomes
Target vessel stenosis rate
Time frame: Within 5-7 days after MT
Perioperative complications
Time frame: Within 30 days after MT
Neurological function evaluation
Time frame: Within 90 days after MT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 28366071Abraham 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.
- Background: PubMed 29655219Perren 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.
- Background: PubMed 34785610Krishnan 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.
- Background: PubMed 32139427Lindenholz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 80mg and Atorvastatin 20mg in people with Mechanical Thrombectomy and Acute Ischemic Stroke, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao-Jun Teng, M.D. (+86-02583272121, gjteng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral vascular wall damage (time frame: within 5-7 days after MT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912686, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.