Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke (EMPHASIS)

August 3, 2023 updated by: yilong Wang, Beijing Tiantan Hospital

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to evaluate the efficacy and safety of 4.5-days Minocycline versus placebo in patients with moderate to severe acute ischemic stroke within 72 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation and thrombo-inflammation at different time points in patients with moderate to severe acute ischemic stroke within 72 hours of onset.

The primary objective is to evaluate the effect of Minocycline in improving the level of mRS score to 0-1 in patients with moderate to severe acute ischemic stroke within 72 hours of onset.

The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants were interviewed at screening/baseline period, 24±2 hours, 6±1 days, 90±7 days after randomization, and when events occurred.

Study Type

Interventional

Enrollment (Estimated)

1672

Phase

  • Phase 3

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
      • Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
          • yilong Wang, MD, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. 18≤Age≤80 years old;
  2. Patients with acute ischemic stroke confirmed by CT or MRI within 72 hours of onset;
  3. 4≤NIHSS≤25, and Ia≤1;
  4. First stroke or mRS 0-1 before the onset of current stroke;
  5. Patients or his/her legal representatives are able to understand and sign the informed consent.

Exclusion criteria:

  1. History of pseudomembranous colitis or antibiotic-related colitis.
  2. Allergic to tetracycline antibiotics or any component of the investigational drug.
  3. Known to be resistant to other tetracyclines.
  4. Took tetracycline antibiotics within previous one week.
  5. Known community-acquired bacterial infection, such as pneumonia or urinary tract infection.
  6. History of intracranial hemorrhagic diseases within previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.
  7. Intracranial tumors, vascular malformations and other intracranial space-occupying lesions.
  8. Rare or unknown etiology of LVO, such as dissection and vasculitis.
  9. Severe hepatic insufficiency, renal insufficiency or receiving dialysis before randomization for various reasons (Severe hepatic insufficiency was defined as ALT >3 times the upper limit of normal value or AST >3 times the upper limit of normal value; Severe renal insufficiency was defined as creatinine > 3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate<30 ml/min/1.73m2).
  10. Bleeding tendency (including but not limited to): platelet count <100×109/L; Administration of oral warfarin and INR>2; Administration of heparin within previous 48 hours and APTT≥35s; Hereditary bleeding disorders, such as hemophilia.
  11. Received any of the following treatments within previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).
  12. History of intracranial or spinal surgery within previous 3 months; History of therapeutical surgery or major physical trauma within previous 1 month.
  13. Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.
  14. Life expectancy of less than 6 months due to advanced stage of comorbidity.
  15. Participated in other interventional clinical trials within previous 3 months.
  16. Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Minocycline treatment group
Minocycline Hydrochloride Capsules (50 mg per capsule) The first dose should be given immediately after randomization (within 30 minutes); 200mg (4 capsules) for the first dose; Subsequently, 100mg (2 capsules) will be administered once every 12 hours, a total of 9 times (lasting 4.5 days; the subject with dysphagia will be administrated through a nasal feeding tube)
Drug: Minocycline hydrochloride capsule
50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
Placebo Comparator: Minocycline placebo-control group
Placebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline) The method of administration was the same as that of treatment group.
Drug: Placebo capsules of Minocycline hydrochloride capsules
50 mg per capsule, containing 0mg of Minocycline Hydrochloride.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score 0-1
Time Frame: At 90±7 days after randomization.
Modified Rankin Scale score.
At 90±7 days after randomization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score.
Time Frame: At 90±7 days after randomization.
Modified Rankin Scale score.
At 90±7 days after randomization.
Changes in NIHSS score compared with baseline score.
Time Frame: At 24±1 hours and 6±1 days after randomization.
NIHSS score
At 24±1 hours and 6±1 days after randomization.
Changes in hs-CRP level compared with baseline level.
Time Frame: At 6±1 days after randomization.
hs-CRP was examined to evaluate the level of systematic inflammation
At 6±1 days after randomization.
Early neurological deterioration.
Time Frame: At 24±2 hours and 6±1 days after randomization.
Early neurological deterioration was defined as any new neurological symptoms or signs that occur within several hours or days of onset, as well as the progression of existing neurological deficit symptoms or signs.
At 24±2 hours and 6±1 days after randomization.
Recurrent stroke.
Time Frame: At 90±7 days after randomization.
Recurrent stroke includes recurrent ischemic stroke and recurrent hemorrhagic stroke.
At 90±7 days after randomization.
Recurrent ischemic stroke.
Time Frame: At 90±7 days after randomization.
The condition of recurrent ischemic stroke.
At 90±7 days after randomization.
Combined vascular events.
Time Frame: At 90±7 days after randomization.
Combined vascular events referred to stroke, myocardial infarction, and vascular death.
At 90±7 days after randomization.
Quality of life (EQ-5D) score.
Time Frame: At 90±7 days after randomization.
Scores of EuroQol (Quality of life) -5 Dimensions.
At 90±7 days after randomization.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the levels of venous neuroinflammation indicators and thrombotic inflammation indicators compared with baseline levels.
Time Frame: At 24±2 hours and 6±1 days after randomization.
Venous neuroinflammation indicators (NF-L, S100B, copeptin, etc.) and thrombotic inflammation indicators (plasma sGPVI, sADAMTS 13, sCD40L, sP-selectin, etc.)
At 24±2 hours and 6±1 days after randomization.
Cerebral hemodynamic function.
Time Frame: At 6±1 days and 90±7 days after randomization.
Cerebral hemodynamics was reflected by cerebral autoregulation function, and autonomic nervous function was evaluated by heart rate variability.
At 6±1 days and 90±7 days after randomization.
Changes in the levels of venous intestinal flora metabolites compared with baseline levels
Time Frame: At 6±1 days after randomization.
plasma TMAO and its precursors, etc.
At 6±1 days after randomization.

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Collaborators

NeuroDawn Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Yilong Wang, PhD+MD, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

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)

May 19, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-007-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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