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

2026년 5월 19일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

234

단계

  • 2 단계
  • 3단계

연락처 및 위치

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연구 연락처

연구 장소

    • Hubei
      • Wuhan, Hubei, 중국, 430000
        • 모병
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
미노사이클린염산염 50mg이 들어있는 캡슐당 50mg입니다.
위약 비교기: 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.
1캡슐당 50mg, 미노사이클린염산염 0mg 함유.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Functional independence
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Ordinal distribution of mRS
기간: 90±7 days
The shift analysis of mRS at 90±7 days
90±7 days
Ambulatory or bodily needs-capable or better
기간: 90±7 days
Rate of mRS 0-3 at 90±7 days
90±7 days
Quality of life (EQ-5D-5L)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
전체 원인 사망률
기간: 90±7일
90±7일 시점의 전원인 사망률
90±7일
Symptomatic intracranial hemorrhage (sICH)
기간: 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
기간: 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
기간: 90±7 days
Incidences of adverse events and serious adverse events
90±7 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

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

간행물 및 유용한 링크

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 19일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 19일

마지막으로 확인됨

2026년 5월 1일

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