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Tests treatment safety and results for Ischaemic Stroke
Official title Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis
ClinicalTrials.gov ID: NCT07526987
What this study is testing
What is Minocycline Hydrochloride Capsule (50 mg per capsule)?
Minocycline Hydrochloride Capsule (50 mg per capsule) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischaemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
- 6≤NIHSS≤25, and Ia≤1;
You likely can't join 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...
See the full eligibility criteria
- 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...
- The study drug can be applied before intravenous thrombolysis or within 2 hours after the initiation of intravenous thrombolysis;
- 6≤NIHSS≤25, and Ia≤1;
- Signed informed consent.
- 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...
- 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;
- Any other condition that is not suitable for participating in this clinical trial, such as inability to understand or follow the study procedures due to physical, cognitive, emotional, or mental disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Liaocheng, Shandong, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liaocheng, Shandong, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.