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NCT Number: NCT05487417

Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hospital

Xi'an, China

Location status: Recruiting

Location contact

Wen Jiang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion;
  • Age 18-85 years old;
  • The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging;
  • 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;
  • Preoperative NIHSS score ranges from 6 to 30 points;
  • Sign the informed consent form;

Exclusion criteria

  • There are contraindications for mechanical thrombectomy;
  • No revascularization therapy was performed during the operation or the TICI score after revascularization therapy was less than 2b;
  • There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc;
  • There is evidence that the patient has bacterial endocarditis, aortic dissection, arteritis or venous cerebral infarction;
  • Renal insufficiency or hepatic insufficiency (serum creatinine >2.0 mg/dL or 180 µmol/L; liver function greater than 3 times the normal value);
  • Known history of congestive heart failure (requiring dietary or medication changes or hospitalization) within 6 months, or myocardial infarction within 6 months;
  • 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;
  • Pre-existing neurological deficits or history of dementia;
  • There are infectious diseases that require antibiotic treatment before the disease;
  • Allergic to tetracyclines or unable to take minocycline for other reasons;
  • Minocycline could not be given within 1 hour after recanalization;
  • Pregnant patients;
  • Participated in another clinical trial within 30 days before inclusion in the study.
  • Refuse to sign the informed consent form.

Treatment and study plan

Minocycline

Drug

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.

Primary outcomes

  1. Change in infarct volume from baseline to day 5

    Time frame: 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 outcomes

  1. Functional outcome at 3 months after onset

    Time frame: 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.

  2. Favourable outcome at 3 months after onset

    Time frame: 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.

  3. Excellent outcome at 3 months after onset

    Time frame: 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.

  4. Improvement of neurological function compared with baseline

    Time frame: 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.

  5. Improvement of activity of daily living at 3 months after onset

    Time frame: 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

  6. Incidence of intracranial hemorrhage at day 1 after onset

    Time frame: Day 1 after onset

    Intracranial hemorrhage is measured by CT scan. Images are processed by RAPID ICH software.

  7. Mortality at 3 months after onset

    Time frame: 3 months after onset

    The investigators record all-cause mortality

  8. Infarct volume at day 5 after onset

    Time frame: Day 5 after onset

    Day 5 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software.

  9. Length of hospital stay and length of Intensive Care Unit (ICU) stay

    Time frame: 3 months after onset

    How long the patients stay in hospital, and how long the patients stay in ICU

Other outcomes

  1. Safety outcomes: adverse events and serious adverse events

    Time frame: 3 months after onset

    Safety outcomes were incidences of adverse events and serious adverse events that were related or not related to the study treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Yang, Ph.D

CONTACT

[email protected]

86-029-84771319

Wen Jiang, Ph.D

CONTACT

[email protected]

86-029-84771319

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • Baoji High-tech Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First People's Hospital of Xianyang
  • Jingyang County Hospital
  • Northwest University First Hospital
  • Pucheng County Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • The First Hospital of Yulin
  • Weinan Central Hospital
  • Xi'An Daxing Hospital
  • Xi'an Gaoxin Hospital
  • Xi'an No.3 Hospital
  • Xi'an No.9 Hospital
  • Xi'an XD Group Hospital
  • Yan'an People's Hospital
  • Yan'an University Xianyang Hospital
  • Yulin No.2 Hospital
  • Yuncheng Central Hospital

Registry information

Official study title

Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy

Acronym: MIST-A

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2022
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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