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NCT05512910

PHASE4

Minocycline for Acute Ischemic Stroke Undergoing Endovascular Treatment Due to Basilar Artery Occlusion (MIST-B)

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Minocycline for Acute Ischemic Stroke Undergoing Endovascular Treatment Due to Basilar Artery Occlusion: a Randomized, Open-label, Proof of Concept Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-03-04

Completion Date

2025-06-04

Last Updated

2025-05-30

Healthy Volunteers

Conditions

Ischemic Stroke, Acute Minocycline Endovascular Treatment Basilar Artery Occlusion

Interventions

DRUG

Minocycline

200 mg minocycline orally or via feeding tube, followed by 100 mg every 12 hours times for a total of 5 days. If vomiting occurs within half an hour of the first dose, the clinician should assess the necessary of re-administering 100mg based on the severity of vomiting. Considering the risk of difficulty in feeding tube before EVT, minocycline administered within one hours after EVT is acceptable.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. 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. 3. Last known well to groin puncture between 0 to 24 hours, whether or not patients had thrombolysis with rt-PA. 4. Pre-stroke mRS score of 0-1. 5. Baseline expanded NIHSS (e-NIHSS) score ≥ 6. 6. Signed Informed Consent obtained. 7. 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. Exclusion Criteria: 1. Age\<18 years old. 2. Complete cerebellar infarct with significant mass effect or has the imaging features of acute hydrocephalus in NCCT. 3. Intracranial hemorrhage. 4. Previous stroke in the past 90 days; 5. cardiopulmonary resuscitation was performed within 10 days prior to onset. 6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, INR \>3, or platelet\<40×109/L. 7. Glucose \<2.2 or \>22 mmol/L. 8. Systolic blood pressure persistently\>185mmHg post-MT despite antihypertensive intervention; Diastolic blood pressure persistently\>110mmHg post-MT despite antihypertensive intervention. 9. Acute or chronic renal failure of CKD grade 3-4. 10. Known allergy or hypersensitivity to contrast dye or tetracycline group of drugs. 11. Epileptic seizure at symptom onset. 12. Life expectancy (except for stroke) \< 3 months. 13. Female who is pregnancy or breastfeeding, or whom do not use effective contraception at childbearing age. 14. Pre-existing mental illness that interferes with neurological evaluation. 15. Known current participation in another clinical investigation with experimental drug. 16. Unlikely to be available for 90 days follow-up.

Locations (1)

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China