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- Ensaio Clínico NCT07594314
Minocycline After Successful Endovascular Thrombectomy Recanalization in Acute Anterior Circulation Large Vessel Occlusion (ATTRACTION-MINOA)
Safety and Efficacy of Adjunctive Minocycline After Successful Endovascular Thrombectomy Recanalization for Acute Anterior Circulation Large Vessel Occlusion - A Multicenter, Prospective, Double-blind, Randomized Trial
Endovascular thrombectomy (EVT) improves outcomes in patients with acute large vessel occlusion (LVO). However, despite successful recanalization rates exceeding 80%, fewer than 50% of patients achieve favorable functional outcomes at 90 days, indicating a high rate of futile recanalization. Potential mechanisms include no-reflow, reperfusion injury, and microcirculatory dysfunction, which are closely associated with post-recanalization neuroinflammation.
Minocycline is a second-generation tetracycline with pleiotropic neuroprotective effects, including inhibition of microglial activation, reduction of inflammatory mediators, suppression of matrix metalloproteinases, attenuation of oxidative stress, and preservation of blood-brain barrier integrity. Prior preclinical and clinical studies suggest that minocycline may improve neurological outcomes in acute ischemic stroke.
This study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate the safety and efficacy of adjunctive minocycline in patients with acute anterior circulation LVO who achieve successful recanalization after EVT. The trial will assess whether early administration of minocycline improves functional outcomes and reduces futile recanalization.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Xiang Luo
- Número de telefone: +86-13349893413
- E-mail: flydottjh@163.com
Locais de estudo
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Hubei
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Wuhan, Hubei, China, 430000
- Recrutamento
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contato:
- Xiang Luo
- Número de telefone: +86-27-83663323
- E-mail: flydottjh@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥18 years;
- Pre-stroke mRS score of 0-1;
- Time from symptom onset to randomization ≤24 hours, including wake-up stroke or unwitnessed stroke. Symptom onset is defined as the last known well time;
- Baseline NIHSS score of 6-25;
- ASPECTS ≥6 on non-contrast CT or DWI;
- Clinical symptoms attributable to acute occlusion at one of the following sites, confirmed by CTA, MRA, or DSA: intracranial internal carotid artery, M1 segment of the middle cerebral artery, or M2 trunk of the MCA;
- Successful recanalization defined as mTICI 2b-3 after mechanical thrombectomy, with no evidence of secondary embolization in non-target vessels; or spontaneous improvement to mTICI 2b-3 on diagnostic angiography prior to thrombectomy with no planned intervention;
- Ability of the patient or legally authorized representative to provide written informed consent.
Exclusion Criteria:
- Acute intracranial hemorrhage on CT or MRI;
- Bilateral acute stroke or multiple intracranial large vessel occlusions;
- Isolated extracranial internal carotid artery occlusion;
- History of pseudomembranous colitis or antibiotic-associated colitis;
- Known allergy to tetracycline antibiotics, any component of the investigational drug, radiocontrast agents, or nitinol materials;
- Known resistance to tetracycline antibiotics;
- Use of tetracycline antibiotics within 7 days prior to randomization;
- History of intracranial hemorrhage within the past 3 months, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
- Intracranial tumors, vascular malformations, or other space-occupying intracranial lesions;
- History of intracranial or spinal surgery within the past 3 months;
- History of major surgery or significant trauma within the past 1 month;
- Receipt of any of the following treatments within the past 3 months: systemic retinoic acid or androgen/antiandrogen therapy (e.g., anabolic steroids, spironolactone);
- Platelet count <100 × 10⁹/L;
- Severe hepatic insufficiency, chronic hemodialysis, or severe renal insufficiency (defined as estimated glomerular filtration rate <30 mL/min or serum creatinine >265.2 μmol/L [3.0 mg/dL]);
- Women who are pregnant or lactating, or who have a positive pregnancy test prior to randomization;
- Life expectancy <6 months (e.g., due to malignancy or severe cardiopulmonary disease);
- Participation in another interventional clinical trial that may affect outcome assessment;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation or poses significant risk (e.g., inability to understand or comply with study procedures or follow-up due to psychiatric, cognitive, or emotional disorders).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Minocycline group
Participants with successful recanalization (mTICI 2b/3) after endovascular thrombectomy will receive minocycline as soon as possible after randomization.
A loading dose of 200 mg of minocycline administered orally, followed by a maintenance dose of 100 mg every 12 hours for 4 days (total of 9 doses).
For patients with swallowing dysfunction, administration via a feeding tube will be permitted.
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50 mg por cápsula, contendo 50 mg de Cloridrato de Minociclina.
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Comparador de Placebo: placebo group
Participants with successful recanalization (mTICI 2b/3) after endovascular thrombectomy will receive placebo as soon as possible after randomization.
Placebo was administered in the same manner as minocycline group.
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50 mg por cápsula, contendo 0 mg de Cloridrato de Minociclina.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Excellent outcome
Prazo: 90±7 days
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Rate of modified Rankin scale (mRS) 0-1 at 90±7 days 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).
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90±7 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Independência funcional
Prazo: 90±7 dias
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Taxa de mRS 0-2 aos 90±7 dias
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90±7 dias
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Ordinal distribution of mRS
Prazo: 90±7 days
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The shift analysis of mRS at 90±7 days
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90±7 days
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Ambulatory or bodily needs-capable or better
Prazo: 90±7 days
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Rate of mRS 0-3 at 90±7 days
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90±7 days
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Quality of life (EQ-5D-5L)
Prazo: 90±7 days
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The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score at 90±7 days The EQ-5D-5L is a standardized, preference-based measure of health-related quality of life covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five severity levels.
The EQ-5D-5L index score typically ranges from less than 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better quality of life.
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90±7 days
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Neurologic deficit (NIHSS score) changes
Prazo: 24±12 hours and 6±1 days
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The change of NIHSS score from baseline The NIHSS is a standardized clinical scale used to quantify neurologic impairment in stroke patients.
The total score ranges from 0 to 42, with higher scores indicating more severe neurologic deficit.
The outcome is defined as the change in NIHSS score from baseline, where a greater negative change reflects greater neurologic improvement.
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24±12 hours and 6±1 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortalidade por todas as causas
Prazo: 90±7 dias
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Mortalidade por todas as causas aos 90±7 dias
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90±7 dias
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Symptomatic intracranial hemorrhage (sICH)
Prazo: 24±12 hours and 6±1 days
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Rate of sICH after randomization (Heidelberg Bleeding Classification)
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24±12 hours and 6±1 days
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Any intracranial hemorrhage
Prazo: 24±12 hours and 6±1 days
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Rate of any intracranial hemorrhage after randomization (Heidelberg Bleeding Classification)
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24±12 hours and 6±1 days
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Adverse events and serious adverse events
Prazo: 90±7 days
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Incidences of adverse events and serious adverse events
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90±7 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Xiang Luo, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Isquemia Cerebral
- Infarte
- Necrose
- Isquemia
- Derrame
- Condições Patológicas, Sinais e Sintomas
- AVC Isquêmico
- Infarto Cerebral
- sequência de ciclopia
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos aromáticos policíclicos
- Hidrocarbonetos, aromáticos
- Compostos policíclicos
- Nafthacenos
- Tetraciclinas
- Minociclina
Outros números de identificação do estudo
- TJ-IRB202605009
Plano para dados de participantes individuais (IPD)
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