Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: NeuroDawn Pharmaceutical Co., Ltd.
• Treatments: Minocycline

Criteria

Inclusion criteria:

1. 18≤Age≤80 years old;

2. Patients with acute ischemic stroke confirmed by CT or MRI within 72 hours of onset;

3. 4≤NIHSS≤25, and Ia≤1;

4. First stroke or mRS 0-1 before the onset of current stroke;

5. Patients or his/her legal representatives are able to understand and sign the informed consent.

Exclusion criteria:

1. History of pseudomembranous colitis or antibiotic-related colitis.

2. Allergic to tetracycline antibiotics or any component of the investigational drug.

3. Known to be resistant to other tetracyclines.

4. Took tetracycline antibiotics within previous one week.

5. Known community-acquired bacterial infection, such as pneumonia or urinary tract infection.

6. History of intracranial hemorrhagic diseases within previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.

7. Intracranial tumors, vascular malformations and other intracranial space-occupying lesions.

8. Rare or unknown etiology of LVO, such as dissection and vasculitis.

9. Severe hepatic insufficiency, renal insufficiency or receiving dialysis before randomization for various reasons (Severe hepatic insufficiency was defined as ALT >3 times the upper limit of normal value or AST >3 times the upper limit of normal value; Severe renal insufficiency was defined as creatinine > 3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate<30 ml/min/1.73m2).

10. Bleeding tendency (including but not limited to): platelet count <100×109/L; Administration of oral warfarin and INR>2; Administration of heparin within previous 48 hours and APTT≥35s; Hereditary bleeding disorders, such as hemophilia.

11. Received any of the following treatments within previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).

12. History of intracranial or spinal surgery within previous 3 months; History of therapeutical surgery or major physical trauma within previous 1 month.

13. Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.

14. Life expectancy of less than 6 months due to advanced stage of comorbidity.

15. Participated in other interventional clinical trials within previous 3 months.

16. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.