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Minocycline After Successful Endovascular Thrombectomy Recanalization in Posterior Circulation Arterial Occlusion (ATTRACTION-MINOP)

19 de maio de 2026 atualizado por: Xiang Luo

Safety and Efficacy of Adjunctive Minocycline After Successful Endovascular Thrombectomy Recanalization for Acute Posterior Circulation Arterial Occlusion - A Multicenter, Prospective, Double-blind, Randomized Trial

Acute ischemic stroke (AIS) is a leading cause of mortality and long-term disability worldwide. Among these, stroke caused by large vessel occlusion (LVO) are associated with particularly poor outcomes. Multiple randomized controlled trials have demonstrated that endovascular thrombectomy (EVT) significantly improves clinical outcomes in patients with acute LVO and is recommended as the standard of care by current guidelines. Posterior circulation strokes account for approximately 20% of all ischemic strokes and are generally associated with worse prognosis than anterior circulation strokes, especially in patients with basilar artery occlusion, who have a markedly increased risk of death or severe disability. Despite EVT treatment, more than three-quarters of these patients remain dead or functionally dependent at 90 days, indicating substantial room for improvement.

Successful recanalization and restoration of effective cerebral perfusion are critical for achieving favorable outcomes. However, although recanalization rates exceed 80% with current thrombectomy techniques, fewer than 40 of patients achieve good functional outcomes at 90 days, suggesting a high incidence of futile recanalization. The underlying mechanisms may include no-reflow, reperfusion injury, and microcirculatory dysfunction, all of which are closely associated with post-recanalization neuroinflammation.

Minocycline is a second-generation tetracycline with pleiotropic neuroprotective properties, including inhibition of microglial activation, reduction of inflammatory mediators, suppression of matrix metalloproteinases, attenuation of oxidative stress, and preservation of blood-brain barrier integrity. Preclinical and clinical studies suggest that minocycline may improve neurological outcomes in patients with AIS.

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 posterior circulation arterial occlusion who achieve successful recanalization after EVT. The trial will assess whether early administration of minocycline improves functional outcomes and reduces the incidence of futile recanalization.

Visão geral do estudo

Descrição detalhada

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 posterior circulation arterial occlusion who achieve successful recanalization after EVT. Eligible patients will be randomized in a 1:1 ratio to receive minocycline or placebo as soon as possible after randomization. Participants assigned to the intervention group will receive 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). Patients in the control group will receive a matching placebo according to the same schedule. For patients with swallowing dysfunction, administration via a feeding tube will be permitted. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days. A total of 234 participants (117 per group) will be enrolled.

Tipo de estudo

Intervencional

Inscrição (Estimado)

234

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recrutamento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age ≥18 years;
  2. Pre-stroke mRS score of 0-1;
  3. 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;
  4. Baseline NIHSS score ≥6;;
  5. Posterior Circulation ASPECTS ≥6 on non-contrast CT or DWI;
  6. Clinical symptoms attributable to acute occlusion of the intracranial vertebral artery or basilar artery, confirmed by CTA, MRA, or DSA;
  7. 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;
  8. Ability of the patient or legally authorized representative to provide written informed consent.

Exclusion Criteria:

  1. Acute intracranial hemorrhage on CT or MRI;
  2. Occlusion involving both anterior and posterior circulations on CTA, MRA, or DSA (except in patients with a prior history of anterior circulation occlusion);
  3. Complete bilateral thalamic infarction or bilateral brainstem infarction on CT or MRI;
  4. Cerebellar infarction with significant mass effect or compression of the fourth ventricle on CT or MRI;
  5. Vascular anatomy on CTA, MRA, or DSA that is severely tortuous, demonstrates significant anatomical variation, or shows severe stenosis or dissection precluding navigation of thrombectomy devices to the target vessel;
  6. History of pseudomembranous colitis or antibiotic-associated colitis;
  7. Known allergy to tetracycline antibiotics, any component of the investigational drug, radiocontrast agents, or nitinol materials;
  8. Known resistance to tetracycline antibiotics;
  9. Use of tetracycline antibiotics within 7 days prior to randomization;
  10. History of intracranial hemorrhage within the past 3 months, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
  11. Intracranial tumors, vascular malformations, or other space-occupying intracranial lesions;
  12. History of intracranial or spinal surgery within the past 3 months;
  13. History of major surgery or significant trauma within the past 1 month;
  14. Receipt of any of the following treatments within the past 3 months: systemic retinoic acid or androgen/antiandrogen therapy (e.g., anabolic steroids, spironolactone);
  15. Platelet count <100 × 10⁹/L;
  16. 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]);
  17. Women who are pregnant or lactating, or who have a positive pregnancy test prior to randomization;
  18. Life expectancy <6 months (e.g., due to malignancy or severe cardiopulmonary disease);
  19. Participation in another interventional clinical trial that may affect outcome assessment;
  20. 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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
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.
50 mg por cápsula, contendo 50 mg de Cloridrato de Minociclina.
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.
50 mg por cápsula, contendo 0 mg de Cloridrato de Minociclina.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Functional independence
Prazo: 90±7 days
Rate of mRS 0-2 at 90±7 days Defined as an modified Rankin Scale (mRS) score of 0 to 2. The mRS scores range from 0 (no symptoms) to 5 (severe disability) and 6 (death).
90±7 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ordinal distribution of mRS
Prazo: 90±7 days
The shift analysis of mRS at 90±7 days
90±7 days
Ambulatory or bodily needs-capable or better
Prazo: 90±7 days
Rate of mRS 0-3 at 90±7 days
90±7 days
Quality of life (EQ-5D-5L)
Prazo: 90±7 days
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.
90±7 days
Neurologic deficit (NIHSS score) changes
Prazo: 24±12 hours and 6±1 days
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.
24±12 hours and 6±1 days
Excellent outcome
Prazo: 90±7 days
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).
90±7 days

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Mortalidade por todas as causas
Prazo: 90±7 dias
Mortalidade por todas as causas aos 90±7 dias
90±7 dias
Symptomatic intracranial hemorrhage (sICH)
Prazo: 24±12 hours and 6±1 days
Rate of sICH after randomization (Heidelberg Bleeding Classification)
24±12 hours and 6±1 days
Any intracranial hemorrhage
Prazo: 24±12 hours and 6±1 days
Rate of any intracranial hemorrhage after randomization (Heidelberg Bleeding Classification)
24±12 hours and 6±1 days
Adverse events and serious adverse events
Prazo: 90±7 days
Incidences of adverse events and serious adverse events
90±7 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de maio de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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