Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

Last updated: July 21, 2024
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Stroke

Cerebral Ischemia

Cardiac Ischemia

Treatment

Minocycline

Clinical Study ID

NCT05487417
XJLL-KY20222186
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients with acute cerebral infarction of anterior circulation accompanied by largevessel occlusion;

  2. Age 18-85 years old;

  3. The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomydetermined by multimodal imaging;

  4. The time of onset 6-24 hours, DWI shows an infarct volume less than 1/3 of the MCAblood supply area; the time of onset ≤ 6 hours, the ASPECTS(Alberta Stroke ProgramEarly CT Score) is ≥6;

  5. Preoperative NIHSS score ranges from 6 to 30 points;

  6. Sign the informed consent form;

Exclusion

Exclusion Criteria:

  1. There are contraindications for mechanical thrombectomy;

  2. No revascularization therapy was performed during the operation or the TICI scoreafter revascularization therapy was less than 2b;

  3. There are other major central nervous system diseases, such as brain injury, braintumor, 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 changesor hospitalization) within 6 months, or myocardial infarction within 6 months;

  7. There is evidence of any other life-threatening or severe diseases that may hinderthe 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.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Minocycline
Phase: 4
Study Start date:
November 01, 2022
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Xijing Hospital

    Xi'an,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.