NCT05512910Active, not recruitingPhase 4
Minocycline for Acute Ischemic Stroke Undergoing Endovascular Treatment Due to Basilar Artery Occlusion (MIST-B)
Minocycline for Acute Ischemic Stroke Undergoing Endovascular Treatment Due to Basilar Artery Occlusion: a Randomized, Open-label, Proof of Concept Study
Source: ClinicalTrials.gov · Last updated 30 May 2025
Brief summary (registry, in English)
This is a multi-center, evaluator-blinded, randomized, open-label, proof of concept trial to explore possible beneficial effect of adjunctive oral minocycline on acute ischemic stroke (AIS) undergoing endovascular treatment due to basilar artery occlusion (BAO). Minocycline has excellent safety profiles, have been previously demonstrated individually to reduce infarction in animal models of stroke, and have potentially mechanisms of antioxidant, anti-inflammatory, anti-apoptotic and protection of blood-brain barrier. However, it is not known whether minocycline can reduce futile recanalization of endovascular treatment, and improve the outcome of patients with AIS due to BAO. Eligible and willing subjects will be randomly assigned to the treatment group or the control group. The treatment group will receive 200 mg oral minocycline, followed by 100 mg every 12 hours times for a total of 5 days. Both groups will receive endovascular thrombectomy and standard medical. The treatment with minocycline will start as soon as possible after randomization. Considering the risk of difficulty in feeding tube before EVT, minocycline administered within one hours after EVT is acceptable. Measures of stroke severity and disability will be recorded at baseline and through the follow-up periods (90 days). The evaluator will be blind to the allocation of patients further minimizing the bias.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 18 Aug 2022
- Start date
- 4 Mar 2023
- Primary completion date
- 11 Mar 2025
- Lead sponsor
- Xijing Hospital
- Diseases
- Stroke
- NCT number
- NCT05512910
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 90
- From 4 Mar 2023 to the primary completion date, 11 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous stroke in the past 90 days;
- cardiopulmonary resuscitation was performed within 10 days prior to onset.
- Known current participation in another clinical investigation with experimental drug.
Other illness
- Intracranial hemorrhage.
- Acute or chronic renal failure of CKD grade 3-4.
- Known allergy or hypersensitivity to contrast dye or tetracycline group of drugs.
- Epileptic seizure at symptom onset.
- Life expectancy (except for stroke) \< 3 months.
- Pre-existing mental illness that interferes with neurological evaluation.
Lab values
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, INR \>3, or platelet\<40×109/L.
- Glucose \<2.2 or \>22 mmol/L.
Age
- Age\<18 years old.
- Female who is pregnancy or breastfeeding, or whom do not use effective contraception at childbearing age.
Other
- Complete cerebellar infarct with significant mass effect or has the imaging features of acute hydrocephalus in NCCT.
- Systolic blood pressure persistently\>185mmHg post-MT despite antihypertensive intervention; Diastolic blood pressure persistently\>110mmHg post-MT despite antihypertensive intervention.
- Unlikely to be available for 90 days follow-up.
Who the study is looking for
- Age ≥ 18 years old.
- Patients had acute symptoms and signs compatible with ischemia due to basilar artery occlusion (BAO), treated with endovascular therapy. Patients with occlusion of intracranial segments of both vertebral arteries (VA) resulting in no flow to the basilar artery (eg, functional basilar artery occlusion) were also eligible for the study.
- Last known well to groin puncture between 0 to 24 hours, whether or not patients had thrombolysis with rt-PA.
- Pre-stroke mRS score of 0-1.
- Baseline expanded NIHSS (e-NIHSS) score ≥ 6.
- Signed Informed Consent obtained.
- Neuroimaging Inclusion Criteria: (1) Proven large vessel occlusion in BAO or VA-V4 occlusion (mTICI score 0-1) determined by MRA or CTA; (2) pc-ASPECTS score ≥ 5 (Non-Contrast CT or DWI); Pons-midbrain-index of\<3.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Xijing Hospital, Fourth Military Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.