- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07594301
Minocycline After Successful Endovascular Thrombectomy Recanalization in Posterior Circulation Arterial Occlusion (ATTRACTION-MINOP)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Xiang Luo
- Telefonní číslo: +86-13349893413
- E-mail: flydottjh@163.com
Studijní místa
-
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Hubei
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Wuhan, Hubei, Čína, 430000
- Nábor
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Kontakt:
- Xiang Luo
- Telefonní číslo: +86-13349893413
- E-mail: flydottjh@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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 ≥6;;
- Posterior Circulation ASPECTS ≥6 on non-contrast CT or DWI;
- Clinical symptoms attributable to acute occlusion of the intracranial vertebral artery or basilar artery, confirmed by CTA, MRA, or DSA;
- 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;
- Occlusion involving both anterior and posterior circulations on CTA, MRA, or DSA (except in patients with a prior history of anterior circulation occlusion);
- Complete bilateral thalamic infarction or bilateral brainstem infarction on CT or MRI;
- Cerebellar infarction with significant mass effect or compression of the fourth ventricle on CT or MRI;
- 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;
- 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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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 na kapsli, obsahující 50 mg minocyklin hydrochloridu.
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Komparátor placeba: 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 na kapsli, obsahující 0 mg minocyklin hydrochloridu.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional independence
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ordinal distribution of mRS
Časové okno: 90±7 days
|
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
Časové okno: 90±7 days
|
Rate of mRS 0-3 at 90±7 days
|
90±7 days
|
|
Quality of life (EQ-5D-5L)
Časové okno: 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
|
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Neurologic deficit (NIHSS score) changes
Časové okno: 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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Excellent outcome
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Úmrtnost ze všech příčin
Časové okno: 90±7 dnů
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Celková úmrtnost za 90±7 dní
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90±7 dnů
|
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Symptomatic intracranial hemorrhage (sICH)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Xiang Luo, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Mrtvice
- Cévní mozková příhoda
- Arteriální okluzivní onemocnění
- cyklopská sekvence
- Organické chemikálie
- Uhlovodíky
- Uhlovodíky, cyklické
- Polycyklické aromatické uhlovodíky
- Uhlovodíky, aromatické
- Polycyklické sloučeniny
- Nafthacenes
- Tetracykliny
- Minocyklin
Další identifikační čísla studie
- TJ-IRB202605010
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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