Acute Ischemic StrokePhase 2/3NCT07594301
Minocycline After Successful Endovascular Thrombectomy Recanalization in Posterior Circulation Arterial Occlusion (ATTRACTION-MINOP)
A Phase 2/3 study testing Minocycline hydrochloride capsule in people with Acute Ischemic Stroke and Endovascular Thrombectomy, run by Xiang Luo at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Thrombectomy, Minocycline
- What is being tested?
- Minocycline hydrochloride capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2026to Dec 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiang Luo, +86-13349893413, flydottjh@163.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy, Minocycline, Posterior Circulation, Arterial Occlusion
- Being tested
- Minocycline hydrochloride capsule, Placebo capsules of Minocycline hydrochloride capsules
- Keywords
- Acute Ischemic Stroke, Endovascular Thrombectomy, Minocycline, Posterior Circulation Arterial Occlusion
- Medical subject headings
- Ischemic Stroke, cyclopia sequence, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride capsuleDrug
50 mg per capsule, containing 50mg of Minocycline Hydrochloride.
Placebo capsules of Minocycline hydrochloride capsulesDrug
50 mg per capsule, containing 0mg of Minocycline Hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo capsules of Minocycline hydrochloride capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence
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).
Measured: 90±7 days
Secondary outcomes (5)
Ordinal distribution of mRS
The shift analysis of mRS at 90±7 days
Measured: 90±7 days
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).
Measured: 90±7 days
Ambulatory or bodily needs-capable or better
Rate of mRS 0-3 at 90±7 days
Measured: 90±7 days
Quality of life (EQ-5D-5L)
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.
Measured: 90±7 days
Neurologic deficit (NIHSS score) changes
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.
Measured: 24±12 hours and 6±1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start19 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Luo, Tongji Hospital
- Investigators
- Xiang Luo, Principal investigator, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594301
- Sponsor's protocol ID
- TJ-IRB202605010
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41628627