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

Primary Purpose

Ischemic Stroke, Acute

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Minocycline
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Ischemic Stroke, Minocycline, Mechanical thrombectomy, Anterior circulation, Neuroprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Minocycline treatment group

Routine treatment group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in infarct volume from baseline to day 7
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

Functional outcome at 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.
Favourable outcome at 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.
Excellent outcome at 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.
Improvement of neurological function compared with baseline
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.
Improvement of activity of daily living at 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
Incidence of intracranial hemorrhage at day 1 after onset
Intracranial hemorrhage is measured by CT scan. Images are processed by RAPID ICH software.
Mortality at 3 months after onset
The investigators record all-cause mortality
Infarct volume at day 7 after onset
Day 7 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software.
Length of hospital stay and length of Intensive Care Unit (ICU) stay
How long the patients stay in hospital, and how long the patients stay in ICU

Full Information

First Posted
July 30, 2022
Last Updated
January 23, 2023
Sponsor
Xijing Hospital
Collaborators
Xi'an No.3 Hospital, Xi'an Gaoxin Hospital, First People's Hospital of Xianyang, Xi'an XD Group Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05487417
Brief Title
Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy
Acronym
MIST-A
Official Title
Effects of Minocycline on Patients With Acute Anterior Circulation Ischemic Stroke Undergoing Intravenous Thrombectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
Collaborators
Xi'an No.3 Hospital, Xi'an Gaoxin Hospital, First People's Hospital of Xianyang, Xi'an XD Group Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute
Keywords
Ischemic Stroke, Minocycline, Mechanical thrombectomy, Anterior circulation, Neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocycline treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine treatment group
Arm Type
No Intervention
Arm Description
Patients were given mechanical thrombectomy and other standard treatment for acute ischemic stroke, without minocycline treatment.
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
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 Outcome Measure Information:
Title
Change in infarct volume from baseline to day 7
Description
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.
Time Frame
Day 7 after onset
Secondary Outcome Measure Information:
Title
Functional outcome at 3 months after onset
Description
Defined by the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death), analyzed for superiority and then for noninferiority.
Time Frame
3 months after onset
Title
Favourable outcome at 3 months after onset
Description
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.
Time Frame
3 months after onset
Title
Excellent outcome at 3 months after onset
Description
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.
Time Frame
3 months after onset
Title
Improvement of neurological function compared with baseline
Description
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.
Time Frame
day 1, day 3, day 5, day 7, and 3 months after onset
Title
Improvement of activity of daily living at 3 months after onset
Description
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
Time Frame
3 months after onset
Title
Incidence of intracranial hemorrhage at day 1 after onset
Description
Intracranial hemorrhage is measured by CT scan. Images are processed by RAPID ICH software.
Time Frame
Day 1 after onset
Title
Mortality at 3 months after onset
Description
The investigators record all-cause mortality
Time Frame
3 months after onset
Title
Infarct volume at day 7 after onset
Description
Day 7 infarct volume is measured by fluid attenuated inversion recovery (FLAIR). Images are processed by imSTROKE software.
Time Frame
Day 7 after onset
Title
Length of hospital stay and length of Intensive Care Unit (ICU) stay
Description
How long the patients stay in hospital, and how long the patients stay in ICU
Time Frame
3 months after onset
Other Pre-specified Outcome Measures:
Title
Safety outcomes: adverse events and serious adverse events
Description
Safety outcomes were incidences of adverse events and serious adverse events that were related or not related to the study treatment.
Time Frame
3 months after onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion; Age ≥ 18 years old; The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging; Sign the informed consent form; Exclusion Criteria: There are contraindications for mechanical thrombectomy; There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc; There was a history of neurological impairment or dementia before the stroke; Chronic renal failure; There are infectious diseases requiring antibiotic treatment; Allergic to tetracyclines or unable to take minocycline for other reasons; Pregnant patients; Refuse to sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Jiang, Ph.D
Phone
86-029-84771319
Email
jiangwen@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yang, Ph.D
Phone
86-029-84771319
Email
fyangx@fmmu.edu.cn
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Jiang

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

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