High-Dose Atorvastatin for Vascular Wall Protection in Thrombectomy Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05912686 |
Recruitment Status :
Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : June 23, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mechanical Thrombectomy Acute Ischemic Stroke | Drug: Atorvastatin 80mg Drug: Atorvastatin 20mg | Phase 4 |
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 |
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. |
- 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
- 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.
- 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.
- Neurological function evaluation [ Time Frame: Within 90 days after MT ]Proportion of patients with good prognosis 3 months after MT surgery.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Gao-Jun Teng, M.D. | +86-02583272121 | gjteng@vip.sina.com |
China, Jiangsu | |
Zhongda Hospital, Southeast University | |
Nanjing, Jiangsu, China, 210009 |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |