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

January 23, 2023 updated by: Wen Jiang-3, Xijing Hospital

Effects of Minocycline on Patients With Acute Anterior Circulation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in infarct volume from baseline to day 7
Time Frame: 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.
Day 7 after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after onset
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 months after onset
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.
3 months after onset
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.
day 1, day 3, day 5, day 7, and 3 months after onset
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
3 months after onset
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.
Day 1 after onset
Mortality at 3 months after onset
Time Frame: 3 months after onset
The investigators record all-cause mortality
3 months after onset
Infarct volume at day 7 after onset
Time Frame: Day 7 after onset
Day 7 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software.
Day 7 after onset
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
3 months after onset

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

July 30, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJLL-KY20222186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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