Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis

NCT07526987 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-B14
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy and safety of minocycline in improving functional outcome among patients with acute ischaemic stroke receiving intravenous thrombolysis.

Conditions

Ischaemic Stroke

Keywords

Ischaemic stroke; Intravenous thrombolysis; Minocycline; Randomized Controlled Trial; Functional outcome

Outcome Measures

Primary Outcomes (1)

• Excellent functional outcome (mRS of 0-1)

  Defined as an modified Rankin Scale (mRS) score of 0 or 1. The mRS scores range from 0 (no symptoms) to 5 (severe disability) and 6 (death).

  90 days

Secondary Outcomes (11)

• Good functional outcome (mRS of 0-2)

  90 days

• Distribution of mRS score

  90 days

• Quality of life score (EQ-5D scale)

  90 days

• Barthel Index score ≥ 95

  90 days

• Changes from baseline of National Institutes of Health Stroke Scale (NIHSS) score

  6 days

Study Arms (2)

Minocycline Therapy

EXPERIMENTAL

This group will receive minocycline hydrochloride capsules.

Drug: Minocycline Hydrochloride Capsule (50 mg per capsule)

Placebo

PLACEBO COMPARATOR

This group will receive placebo of minocycline hydrochloride capsules.

Drug: Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline)

Interventions

Minocycline Hydrochloride Capsule (50 mg per capsule) DRUG

A loading dose of 200 mg will be administered before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis, followed by a maintenance dose of 100 mg every 12 hours for the subsequent 4 days. A total of 9 times will be administered over a period of 4.5 days. Minocycline hydrochloride capsules will be administered orally or via a nasogastric feeding tube if the participant has dysphagia.

Minocycline Therapy

Placebo of Minocycline Hydrochloride Capsule (50 mg per capsule, containing 0 mg of minocycline) DRUG

A loading dose of 200 mg will be administered before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis, followed by a maintenance dose of 100 mg every 12 hours for the subsequent 4 days. A total of 9 times will be administered over a period of 4.5 days. Placebo capsules will be administered orally or via a nasogastric feeding tube if the participant has dysphagia.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years;
• Patients with acute ischaemic stroke confirmed by CT or MRI;
• Having received or planning to receive intravenous thrombolysis within 4.5 hours of onset or within an extended window of 4.5-24 hours based on guideline recommendations (The intravenous thrombolytic drugs include: alteplase, tenecteplase, reteplase or recombinant human prourokinase);
• The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
• ≤NIHSS≤25, and Ia≤1;
• Signed informed consent.

You may not qualify if:

• mRS score ≥ 2 prior to onset of the current stroke;
• History of pseudomembranous colitis or antibiotic-associated colitis;
• Known allergy or intolerance to tetracycline antibiotics or any component of minocycline;
• Known resistance to other tetracyclines;
• Use of tetracycline antibiotics within the past 7 days;
• Presence of a known community-acquired bacterial infection (e.g., pneumonia, urinary tract infection) or any other concurrent infection requiring antibiotic treatment;
• History of intracranial hemorrhagic disease within the past 3 months, for example, parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma.
• Malformation, tumor, abscess, or other major non-ischaemic brain diseases (e.g., multiple sclerosis, other intracranial space-occupying lesions) on baseline cranial CT or MRI;
• Rare or unknown etiology of large vessel occlusion (e.g., arterial dissection, vasculitis);
• History of systemic lupus erythematosus;
• Known severe hepatic insufficiency (ALT or AST \> 3 times of the upper limit of normal), severe renal insufficiency (creatinine \> 3.0 mg/dL \[265.2 μmol/L\], estimated glomerular filtration rate \<30 mL/min/1.73m², or have received dialysis before randomization);
• Use of tretinoin, androgen or antiandrogen treatment (e.g., anabolic steroids, spironolactone) within the past 3 months;
• Pregnant, breastfeeding, or of childbearing potential who are unwilling to use effective contraception throughout the study;
• Presence of a severe non-cardio-cerebrovascular disease with a life expectancy of less than 6 months;
• Participation in any other clinical trial within the past 30 days;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Yilong Wang, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Anxin Wang, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anxin Wang, PhD

CONTACT

8601059976951; wanganxin@bjttyy.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study adopts a double-blind design. Study drugs and placebos are identically packaged. The dosage form, size, color, weight, smell, and taste of the placebo are basically similar to those of the research drug, and there is no risk of blinding. Personnel involved in randomization or potentially exposed to treatment allocation (including pharmacy staff) are not involved in patient care, outcome assessment, or data analysis. Blinded investigators and outcome assessors remain unaware of treatment assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Eligible patients will be randomly assigned in a 1:1 ratio to receive minocycline or placebo. Treatment will be initiated before intravenous thrombolysis or within 2 hours after its initiation, and last for 4.5 days. The primary outcome is an excellent functional outcome (a mRS score of 0 or 1) at 90 days.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)