- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Xiang Luo
- 전화번호: +86-13349893413
- 이메일: flydottjh@163.com
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430000
- 모병
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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연락하다:
- Xiang Luo
- 전화번호: +86-27-83663323
- 이메일: flydottjh@163.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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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.
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미노사이클린염산염 50mg이 들어있는 캡슐당 50mg입니다.
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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.
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1캡슐당 50mg, 미노사이클린염산염 0mg 함유.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Excellent outcome
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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기능적 독립성
기간: 90±7일
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90±7일 시점의 mRS 0-2 비율
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90±7일
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Ordinal distribution of mRS
기간: 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
기간: 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)
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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전체 원인 사망률
기간: 90±7일
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90±7일 시점의 전원인 사망률
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90±7일
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Symptomatic intracranial hemorrhage (sICH)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
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
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TJ-IRB202605009
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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