MIST-A: Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

Sponsor
Xijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05487417
Collaborator
Xi'an No.3 Hospital (Other), Xi'an Gaoxin Hospital (Other), First People's Hospital of Xianyang (Other), Xi'an XD Group Hospital (Other)
180
2
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Treatment
Official Title:
Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Minocycline treatment group

Patients were given minocycline 200mg/d orally from the day of admission for 5 days. At the same time, the patient received mechanical thrombectomy and other standard treatments for acute ischemic stroke.

Drug: Minocycline
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.

No Intervention: Routine treatment group

Patients were given mechanical thrombectomy and other standard treatment for acute ischemic stroke, without minocycline treatment.

Outcome Measures

Primary Outcome Measures

  1. Change in infarct volume from baseline to day 7 [Day 7 after onset]

    Baseline infarct volume is measured by diffusion-weighted imaging (DWI), day 7 infarct volume is measured by fluid attenuated inversion recovery (FLAIR), Images are processed by imSTROKE software.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Mortality at 3 months after onset [3 months after onset]

    The investigators record all-cause mortality

  8. Infarct volume at day 7 after onset [Day 7 after onset]

    Day 7 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 [3 months after onset]

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

Other Outcome Measures

  1. Safety outcomes: adverse events and serious adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion;

  2. Age ≥ 18 years old;

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

  4. Sign the informed consent form;

Exclusion Criteria:
  1. There are contraindications for mechanical thrombectomy;

  2. There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc;

  3. There was a history of neurological impairment or dementia before the stroke;

  4. Chronic renal failure;

  5. There are infectious diseases requiring antibiotic treatment;

  6. Allergic to tetracyclines or unable to take minocycline for other reasons;

  7. Pregnant patients;

  8. Refuse to sign the informed consent form.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Xijing Hospital
  • Xi'an No.3 Hospital
  • Xi'an Gaoxin Hospital
  • First People's Hospital of Xianyang
  • Xi'an XD Group Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wen Jiang-3, Professor, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05487417
Other Study ID Numbers:
  • XJLL-KY20222186
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen Jiang-3, Professor, Xijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022