NCT07594314

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for phase_2

Timeline
31mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2028

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 12, 2026

Last Update Submit

May 17, 2026

Conditions

Acute Ischemic StrokeVessel OcclusionAnterior Circulation Brain InfarctionEndovascular ThrombectomyMinocycline

Keywords

Acute Ischemic StrokeEndovascular ThrombectomyMinocyclineAnterior Circulation Large Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

  • Excellent outcome

    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

Secondary Outcomes (5)

  • Ordinal distribution of mRS

    90±7 days

  • Functional independence

    90±7 days

  • Ambulatory or bodily needs-capable or better

    90±7 days

  • Quality of life (EQ-5D-5L)

    90±7 days

  • Neurologic deficit (NIHSS score) changes

    24±12 hours and 6±1 days

Other Outcomes (4)

  • Symptomatic intracranial hemorrhage (sICH)

    24±12 hours and 6±1 days

  • All-caused mortality

    90±7 days

  • Any intracranial hemorrhage

    24±12 hours and 6±1 days

  • +1 more other outcomes

Study Arms (2)

Minocycline group

EXPERIMENTAL

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.

Drug: Minocycline hydrochloride capsule

placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo capsules of Minocycline hydrochloride capsules

Interventions

Minocycline hydrochloride capsuleDRUG

50 mg per capsule, containing 50mg of Minocycline Hydrochloride.

Minocycline group
Placebo capsules of Minocycline hydrochloride capsulesDRUG

50 mg per capsule, containing 0mg of Minocycline Hydrochloride.

placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

  • Lu Y, Guan L, Wu J, Yang Q, Zhang M, Zhou D, Yang H, Pan Y, Wang L, Qiu B, Liu C, Wang Y, Yang Y, Zhou X, Qu H, Liao X, Liu L, Zhao X, Bath PM, Johnston SC, Amarenco P, Turc G, Shi FD, Wang Y, Wang Y; EMPHASIS Investigators. Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial. Lancet. 2026 Feb 14;407(10529):679-688. doi: 10.1016/S0140-6736(25)01862-8. Epub 2026 Jan 30.

    PMID: 41628627BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeBrain Infarctioncyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Xiang Luo

    Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Luo

CONTACT

+86-13349893413flydottjh@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Minocycline drug used in the study is indistinguishable from the Minocycline placebo (the shape, color, and appearance are identical). In addition, to ensure the blind method, the drug packaging and batch numbers of the two groups are identical, and the packaging batch numbers are uniformly marked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)