Clinical trial NCT05487417: Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy
Official title: Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke, Acute
Keywords: Ischemic Stroke
Minocycline
Mechanical thrombectomy
Anterior circulation
Neuroprotection
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Xi'an No.3 Hospital
name: Xi'an Gaoxin Hospital
name: First People's Hospital of Xianyang
name: Xi'an XD Group Hospital
name: Baoji High-tech Hospital
name: Weinan Central Hospital
name: Xi'An Daxing Hospital
name: Yan'an University Xianyang Hospital
name: The First Hospital of Yulin
name: Northwest University First Hospital
name: Jingyang County Hospital
name: Yulin No.2 Hospital
name: Yan'an people's Hospital
name: Yuncheng Central Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Xi'an No.9 Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Pucheng County Hospital
First posted: 2022-08-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in infarct volume from baseline to day 5
timeFrame: Day 5 after onset
Secondary outcomes:
measure: Functional outcome at 3 months after onset
timeFrame: 3 months after onset
measure: Favourable outcome at 3 months after onset
timeFrame: 3 months after onset
measure: Excellent outcome at 3 months after onset
timeFrame: 3 months after onset
measure: Improvement of neurological function compared with baseline
timeFrame: day 1, day 3, day 5, day 7, and 3 months after onset
measure: Improvement of activity of daily living at 3 months after onset
timeFrame: 3 months after onset
measure: Incidence of intracranial hemorrhage at day 1 after onset
timeFrame: Day 1 after onset
measure: Mortality at 3 months after onset
timeFrame: 3 months after onset
measure: Infarct volume at day 5 after onset
timeFrame: Day 5 after onset
measure: Length of hospital stay and length of Intensive Care Unit (ICU) stay
timeFrame: 3 months after onset
Other outcomes:
measure: Safety outcomes: adverse events and serious adverse events
timeFrame: 3 months after onset
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
Study officials:
References:
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