Minocycline after successful recanalization in acute anterior circulation stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, double-blind, randomized trial will enroll adults who achieve successful recanalization after endovascular thrombectomy for acute anterior circulation large vessel occlusion. Participants will be randomized to receive either minocycline or placebo starting shortly after randomization, with a loading dose of 200 mg followed by 100 mg every 12 hours for 4 days. The primary outcome is the proportion with a favorable outcome (modified Rankin Scale 0-1) at 90 days. The study plans to enroll 860 participants (430 per arm) and allows administration via feeding tube if swallowing is impaired. Safety and efficacy of adjunctive minocycline will be assessed across multiple centers including Tongji Hospital, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Pre-stroke mRS score of 0-1;
3. 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;
4. Baseline NIHSS score of 6-25;
5. ASPECTS ≥6 on non-contrast CT or DWI;
6. 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;
7. 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;
8. Ability of the patient or legally authorized representative to provide written informed consent.

Exclusion Criteria:

1. Acute intracranial hemorrhage on CT or MRI;
2. Bilateral acute stroke or multiple intracranial large vessel occlusions;
3. Isolated extracranial internal carotid artery occlusion;
4. History of pseudomembranous colitis or antibiotic-associated colitis;
5. Known allergy to tetracycline antibiotics, any component of the investigational drug, radiocontrast agents, or nitinol materials;
6. Known resistance to tetracycline antibiotics;
7. Use of tetracycline antibiotics within 7 days prior to randomization;
8. History of intracranial hemorrhage within the past 3 months, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma;
9. Intracranial tumors, vascular malformations, or other space-occupying intracranial lesions;
10. History of intracranial or spinal surgery within the past 3 months;
11. History of major surgery or significant trauma within the past 1 month;
12. Receipt of any of the following treatments within the past 3 months: systemic retinoic acid or androgen/antiandrogen therapy (e.g., anabolic steroids, spironolactone);
13. Platelet count \<100 × 10⁹/L;
14. 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 \[3.0 mg/dL\]);
15. Women who are pregnant or lactating, or who have a positive pregnancy test prior to randomization;
16. Life expectancy \<6 months (e.g., due to malignancy or severe cardiopulmonary disease);
17. Participation in another interventional clinical trial that may affect outcome assessment;
18. 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).

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Xiang Luo — Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001
• Study coordinator: Xiang Luo
• Email: flydottjh@163.com
• Phone: +86-13349893413

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Minocycline after successful reopening of posterior circulation stroke with endovascular therapy

  This trial tests whether adding minocycline after successful thrombectomy helps people recover better from a posterior circulation stroke.

  Recruiting Phase 2/3 Tongji Hospital · Wuhan, Hubei · NCT07594301

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Tenecteplase or Reteplase Bridging Before Thrombectomy in Acute Ischemic Stroke

  This trial tests whether giving tenecteplase or reteplase before mechanical thrombectomy helps people with acute ischemic stroke due to large vessel occlusion, compared with doing thrombectomy alone.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 4 other locations · NCT07748039

• Evaluating a new catheter for treating severe strokes

  This study tests if a new type of catheter can help people with severe strokes recover better than the usual treatment.

  Recruiting The First Affiliated Hospital of University of Science and Technology of China · Hefei, Anhui · NCT06559475

• Using remote ischemic conditioning to improve outcomes in acute ischemic stroke patients undergoing thrombectomy

  This study tests if a new treatment called remote ischemic conditioning can help stroke patients recover better after a procedure to remove a blood clot.

  Recruiting at 60 sites Phase 3 Capital Medical University · Suzhou, Anhui and 69 other locations · NCT06559241

• Evaluating treatment options for stroke patients presenting after 24 hours

  This study is trying to see if a special procedure or the best medical care can help stroke patients who arrive at the hospital more than 24 hours after their symptoms started.

  Recruiting Tianjin Huanhu Hospital · Tianjin, Tianjin Municipality · NCT06200753

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.