Építés alatt – nem éles oldal
Belépés

NCT07594314Toboroz2/3. fázis

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 27.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
2/3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
860 (tervezett)
Első benyújtás
2026. máj. 12.
Kezdés
2026. máj. 21.
Elsődleges befejezés
2028. dec.
Fő szponzor
Xiang Luo
NCT-szám
NCT07594314

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
  • Tervezett résztvevők: 860
  • 2026. máj. 21. és az elsődleges befejezés (2028. dec.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Known allergy to tetracycline antibiotics, any component of the investigational drug, radiocontrast agents, or nitinol materials;
  • Use of tetracycline antibiotics within 7 days prior to randomization;
  • Receipt of any of the following treatments within the past 3 months: systemic retinoic acid or androgen/antiandrogen therapy (e.g., anabolic steroids, spironolactone);
  • Women who are pregnant or lactating, or who have a positive pregnancy test prior to randomization;

Más betegség

  • Acute intracranial hemorrhage on CT or MRI;
  • Bilateral acute stroke or multiple intracranial large vessel occlusions;
  • History of pseudomembranous colitis or antibiotic-associated colitis;
  • History of intracranial hemorrhage within the past 3 months, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
  • History of intracranial or spinal surgery within the past 3 months;
  • History of major surgery or significant trauma within the past 1 month;
  • Life expectancy <6 months (e.g., due to malignancy or severe cardiopulmonary disease);
  • 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).

Laborértékek

  • 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]);

Egyéb

  • Isolated extracranial internal carotid artery occlusion;
  • Known resistance to tetracycline antibiotics;
  • Intracranial tumors, vascular malformations, or other space-occupying intracranial lesions;
  • Participation in another interventional clinical trial that may affect outcome assessment;

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhanKínaToboroz

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.