Ischemic Stroke, Acute
Conditions
Keywords
Ischemic Stroke, Minocycline, Mechanical thrombectomy, Anterior circulation, Neuroprotection
Brief summary
Minocycline is the second generation of tetracycline. Because of its lipophilicity, it has high penetrance of blood-brain barrier. Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular pathways, such as antioxidant, anti-inflammatory, anti apoptotic pathways, and protection of blood-brain barrier. Clinical studies have also shown that minocycline can significantly improve 3-month National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) of patients with ischemic stroke, indicating that minocycline is a potential neuroprotective drug. Minocycline is believed to protect the blood-brain barrier, thereby reducing the ischemia-reperfusion injury caused by mechanical thrombectomy. However, whether minocycline can become a synergistic treatment method of mechanical thrombectomy, there is no clinical research in this area at present. Therefore, investigators carry out the study on the effect of minocycline in patients with acute anterior circulation ischemic stroke after mechanical thrombectomy, and plan to enroll 180 patients. To explore the safety and effectiveness of minocycline in patients with acute ischemic stroke after thrombectomy.
Interventions
DRUGMinocycline
Minocycline is a tetracycline antibiotic. Previous studies have confirmed that its application in stroke patients has good efficacy and safety, suggesting that it could become a synergistic treatment of mechanical thrombectomy.
Sponsors
Xijing Hospital
Xi'an No.3 Hospital
Xi'an Gaoxin Hospital
First People's Hospital of Xianyang
Xi'an XD Group Hospital
Baoji High-tech Hospital
Weinan Central Hospital
Xi'An Daxing Hospital
Yan'an University Xianyang Hospital
The First Hospital of Yulin
Northwest University First Hospital
Jingyang County Hospital
Yulin No.2 Hospital
Yan'an People's Hospital
Yuncheng Central Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an No.9 Hospital
First Affiliated Hospital Xi'an Jiaotong University
Pucheng County Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
In this study, the outcome of minocycline group and routine treatment group was compared. Placebo control was not used, so outcomes assessor blind was used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion; 2. Age 18-85 years old; 3. The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging; 4. The time of onset 6-24 hours, DWI shows an infarct volume less than 1/3 of the MCA blood supply area; the time of onset ≤ 6 hours, the ASPECTS(Alberta Stroke Program Early CT Score) is ≥6; 5. Preoperative NIHSS score ranges from 6 to 30 points; 6. Sign the informed consent form;
Exclusion criteria
1. There are contraindications for mechanical thrombectomy; 2. No revascularization therapy was performed during the operation or the TICI score after revascularization therapy was less than 2b; 3. There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc; 4. There is evidence that the patient has bacterial endocarditis, aortic dissection, arteritis or venous cerebral infarction; 5. Renal insufficiency or hepatic insufficiency (serum creatinine \>2.0 mg/dL or 180 µmol/L; liver function greater than 3 times the normal value); 6. Known history of congestive heart failure (requiring dietary or medication changes or hospitalization) within 6 months, or myocardial infarction within 6 months; 7. There is evidence of any other life-threatening or severe diseases that may hinder the completion of the 3-month follow-up and affect the evaluation of the results; 8. Pre-existing neurological deficits or history of dementia; 9. There are infectious diseases that require antibiotic treatment before the disease; 10. Allergic to tetracyclines or unable to take minocycline for other reasons; 11. Minocycline could not be given within 1 hour after recanalization; 12. Pregnant patients; 13. Participated in another clinical trial within 30 days before inclusion in the study. 14. Refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in infarct volume from baseline to day 5 | Day 5 after onset | Baseline infarct volume is measured by diffusion-weighted imaging (DWI), day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR), Images are processed by imSTROKE software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome at 3 months after onset | 3 months after onset | Defined by the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death), analyzed for superiority and then for noninferiority. |
| Favourable outcome at 3 months after onset | 3 months after onset | Defined as proportion of patients with modified Rankin Scale (mRS) 0-2, which ranges from 0 (no symptoms) to 6 (death), An mRS score of \<3 indicated a favourable outcome, whereas a score of ≥3 indicated a poor outcome. |
| Excellent outcome at 3 months after onset | 3 months after onset | Defined as proportion of patients with modified Rankin Scale (mRS) 0-1, which ranges from 0 (no symptoms) to 6 (death), An mRS score of \<2 indicated a excellent outcome, whereas a score of ≥2 indicated a poor outcome. |
| Improvement of neurological function compared with baseline | day 1, day 3, day 5, day 7, and 3 months after onset | Defined by the National Institute of Health Stroke Scale (NIHSS), which ranges from 0 (no neurological injury) to 42 (severe neurological injury). The assessment time points were baseline, day 1, day 3, day 5, day 7, and 3 months after onset. |
| Improvement of activity of daily living at 3 months after onset | 3 months after onset | Defined by Barthel index (BI), which ranges from 0 (completely lose the ability to live independently) to 100 (complete ability to live independently). The assessment time points were 3 months after onset |
| Incidence of intracranial hemorrhage at day 1 after onset | Day 1 after onset | Intracranial hemorrhage is measured by CT scan. Images are processed by RAPID ICH software. |
| Mortality at 3 months after onset | 3 months after onset | The investigators record all-cause mortality |
| Infarct volume at day 5 after onset | Day 5 after onset | Day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software. |
| Length of hospital stay and length of Intensive Care Unit (ICU) stay | 3 months after onset | How long the patients stay in hospital, and how long the patients stay in ICU |
Countries
China
Outcome results
None listed