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Minocycline After Successful Endovascular Thrombectomy Recanalization in Acute Anterior Circulation Large Vessel Occlusion (ATTRACTION-MINOA)

22 de mayo de 2026 actualizado por: Xiang Luo

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.

Descripción general del estudio

Descripción detallada

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. 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 0-1 at 90 days. A total of 860 participants (430 per group) will be enrolled.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

860

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Xiang Luo
  • Número de teléfono: +86-13349893413
  • Correo electrónico: flydottjh@163.com

Ubicaciones de estudio

    • Hubei
      • Wuhan, Hubei, Porcelana, 430000
        • Reclutamiento
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contacto:
          • Xiang Luo
          • Número de teléfono: +86-27-83663323
          • Correo electrónico: flydottjh@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 of 6-25;
  5. ASPECTS ≥6 on non-contrast CT or DWI;
  6. 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;
  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. Bilateral acute stroke or multiple intracranial large vessel occlusions;
  3. Isolated extracranial internal carotid artery occlusion;
  4. History of pseudomembranous colitis or antibiotic-associated colitis;
  5. Known allergy to tetracycline antibiotics, any component of the investigational drug, radiocontrast agents, or nitinol materials;
  6. Known resistance to tetracycline antibiotics;
  7. Use of tetracycline antibiotics within 7 days prior to randomization;
  8. History of intracranial hemorrhage within the past 3 months, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
  9. Intracranial tumors, vascular malformations, or other space-occupying intracranial lesions;
  10. History of intracranial or spinal surgery within the past 3 months;
  11. History of major surgery or significant trauma within the past 1 month;
  12. Receipt of any of the following treatments within the past 3 months: systemic retinoic acid or androgen/antiandrogen therapy (e.g., anabolic steroids, spironolactone);
  13. Platelet count <100 × 10⁹/L;
  14. 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]);
  15. Women who are pregnant or lactating, or who have a positive pregnancy test prior to randomization;
  16. Life expectancy <6 months (e.g., due to malignancy or severe cardiopulmonary disease);
  17. Participation in another interventional clinical trial that may affect outcome assessment;
  18. 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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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, que contiene 50 mg de Clorhidrato de Minociclina.
Comparador de placebos: 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, que contiene 0 mg de Clorhidrato de Minociclina.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Excellent outcome
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Independencia funcional
Periodo de tiempo: 90±7 días
Tasa de mRS 0-2 a los 90±7 días
90±7 días
Ordinal distribution of mRS
Periodo de tiempo: 90±7 days
The shift analysis of mRS at 90±7 days
90±7 days
Ambulatory or bodily needs-capable or better
Periodo de tiempo: 90±7 days
Rate of mRS 0-3 at 90±7 days
90±7 days
Quality of life (EQ-5D-5L)
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortalidad por todas las causas
Periodo de tiempo: 90±7 días
Mortalidad por todas las causas a los 90±7 días
90±7 días
Symptomatic intracranial hemorrhage (sICH)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 90±7 days
Incidences of adverse events and serious adverse events
90±7 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Xiang Luo, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de mayo de 2026

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2026

Publicado por primera vez (Actual)

18 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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