Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

NCT ID: NCT05487417

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-09-10

Brief Summary

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Minocycline is the second generation of tetracycline. Because of its lipophilicity, it has high penetrance of blood-brain barrier. Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular pathways, such as antioxidant, anti-inflammatory, anti apoptotic pathways, and protection of blood-brain barrier. Clinical studies have also shown that minocycline can significantly improve 3-month National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) of patients with ischemic stroke, indicating that minocycline is a potential neuroprotective drug. Minocycline is believed to protect the blood-brain barrier, thereby reducing the ischemia-reperfusion injury caused by mechanical thrombectomy. However, whether minocycline can become a synergistic treatment method of mechanical thrombectomy, there is no clinical research in this area at present. Therefore, investigators carry out the study on the effect of minocycline in patients with acute anterior circulation ischemic stroke after mechanical thrombectomy, and plan to enroll 180 patients. To explore the safety and effectiveness of minocycline in patients with acute ischemic stroke after thrombectomy.

Detailed Description

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Conditions

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Ischemic Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
In this study, the outcome of minocycline group and routine treatment group was compared. Placebo control was not used, so outcomes assessor blind was used.

Study Groups

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Minocycline treatment group

Patients were given minocycline 200mg/d orally from the day of admission for 5 days. At the same time, the patient received mechanical thrombectomy and other standard treatments for acute ischemic stroke.

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

Minocycline is a tetracycline antibiotic. Previous studies have confirmed that its application in stroke patients has good efficacy and safety, suggesting that it could become a synergistic treatment of mechanical thrombectomy.

Routine treatment group

Patients were given mechanical thrombectomy and other standard treatment for acute ischemic stroke, without minocycline treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Minocycline

Minocycline is a tetracycline antibiotic. Previous studies have confirmed that its application in stroke patients has good efficacy and safety, suggesting that it could become a synergistic treatment of mechanical thrombectomy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with acute cerebral infarction of anterior circulation accompanied by large vessel occlusion;
2. Age 18-85 years old;
3. The time of onset ≤ 6 hours or ≤ 24 hours suitable for mechanical thrombectomy determined by multimodal imaging;
4. The time of onset 6-24 hours, DWI shows an infarct volume less than 1/3 of the MCA blood supply area; the time of onset ≤ 6 hours, the ASPECTS(Alberta Stroke Program Early CT Score) is ≥6;
5. Preoperative NIHSS score ranges from 6 to 30 points;
6. Sign the informed consent form;

Exclusion Criteria

1. There are contraindications for mechanical thrombectomy;
2. No revascularization therapy was performed during the operation or the TICI score after revascularization therapy was less than 2b;
3. There are other major central nervous system diseases, such as brain injury, brain tumor, multiple sclerosis, etc;
4. There is evidence that the patient has bacterial endocarditis, aortic dissection, arteritis or venous cerebral infarction;
5. Renal insufficiency or hepatic insufficiency (serum creatinine \>2.0 mg/dL or 180 µmol/L; liver function greater than 3 times the normal value);
6. Known history of congestive heart failure (requiring dietary or medication changes or hospitalization) within 6 months, or myocardial infarction within 6 months;
7. There is evidence of any other life-threatening or severe diseases that may hinder the completion of the 3-month follow-up and affect the evaluation of the results;
8. Pre-existing neurological deficits or history of dementia;
9. There are infectious diseases that require antibiotic treatment before the disease;
10. Allergic to tetracyclines or unable to take minocycline for other reasons;
11. Minocycline could not be given within 1 hour after recanalization;
12. Pregnant patients;
13. Participated in another clinical trial within 30 days before inclusion in the study.
14. Refuse to sign the informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an No.3 Hospital

OTHER_GOV

Sponsor Role collaborator

Xi'an Gaoxin Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Xianyang

OTHER

Sponsor Role collaborator

Xi'an XD Group Hospital

UNKNOWN

Sponsor Role collaborator

Baoji High-tech Hospital

UNKNOWN

Sponsor Role collaborator

Weinan Central Hospital

OTHER

Sponsor Role collaborator

Xi'An Daxing Hospital

UNKNOWN

Sponsor Role collaborator

Yan'an University Xianyang Hospital

UNKNOWN

Sponsor Role collaborator

The First Hospital of Yulin

UNKNOWN

Sponsor Role collaborator

Northwest University First Hospital

UNKNOWN

Sponsor Role collaborator

Jingyang County Hospital

UNKNOWN

Sponsor Role collaborator

Yulin No.2 Hospital

OTHER

Sponsor Role collaborator

Yan'an people's Hospital

UNKNOWN

Sponsor Role collaborator

Yuncheng Central Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Xi'an No.9 Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Pucheng County Hospital

UNKNOWN

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen Jiang-3

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing Hospital

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Jiang, Ph.D

Role: CONTACT

86-029-84771319

Fang Yang, Ph.D

Role: CONTACT

86-029-84771319

Facility Contacts

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Wen Jiang

Role: primary

References

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Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.

Reference Type BACKGROUND
PMID: 18815396 (View on PubMed)

Yenari MA, Xu L, Tang XN, Qiao Y, Giffard RG. Microglia potentiate damage to blood-brain barrier constituents: improvement by minocycline in vivo and in vitro. Stroke. 2006 Apr;37(4):1087-93. doi: 10.1161/01.STR.0000206281.77178.ac. Epub 2006 Feb 23.

Reference Type BACKGROUND
PMID: 16497985 (View on PubMed)

Matsukawa N, Yasuhara T, Hara K, Xu L, Maki M, Yu G, Kaneko Y, Ojika K, Hess DC, Borlongan CV. Therapeutic targets and limits of minocycline neuroprotection in experimental ischemic stroke. BMC Neurosci. 2009 Oct 6;10:126. doi: 10.1186/1471-2202-10-126.

Reference Type BACKGROUND
PMID: 19807907 (View on PubMed)

Liao TV, Forehand CC, Hess DC, Fagan SC. Minocycline repurposing in critical illness: focus on stroke. Curr Top Med Chem. 2013;13(18):2283-90. doi: 10.2174/15680266113136660160.

Reference Type BACKGROUND
PMID: 24059465 (View on PubMed)

Yang Y, Salayandia VM, Thompson JF, Yang LY, Estrada EY, Yang Y. Attenuation of acute stroke injury in rat brain by minocycline promotes blood-brain barrier remodeling and alternative microglia/macrophage activation during recovery. J Neuroinflammation. 2015 Feb 10;12:26. doi: 10.1186/s12974-015-0245-4.

Reference Type BACKGROUND
PMID: 25889169 (View on PubMed)

Muhammad S, Planz O, Schwaninger M. Increased Plasma Matrix Metalloproteinase-9 Levels Contribute to Intracerebral Hemorrhage during Thrombolysis after Concomitant Stroke and Influenza Infection. Cerebrovasc Dis Extra. 2016;6(2):50-9. doi: 10.1159/000447750. Epub 2016 Aug 25.

Reference Type BACKGROUND
PMID: 27560521 (View on PubMed)

Fagan SC, Waller JL, Nichols FT, Edwards DJ, Pettigrew LC, Clark WM, Hall CE, Switzer JA, Ergul A, Hess DC. Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. Stroke. 2010 Oct;41(10):2283-7. doi: 10.1161/STROKEAHA.110.582601. Epub 2010 Aug 12.

Reference Type BACKGROUND
PMID: 20705929 (View on PubMed)

Lampl Y, Boaz M, Gilad R, Lorberboym M, Dabby R, Rapoport A, Anca-Hershkowitz M, Sadeh M. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study. Neurology. 2007 Oct 2;69(14):1404-10. doi: 10.1212/01.wnl.0000277487.04281.db.

Reference Type BACKGROUND
PMID: 17909152 (View on PubMed)

Elkins J, Veltkamp R, Montaner J, Johnston SC, Singhal AB, Becker K, Lansberg MG, Tang W, Chang I, Muralidharan K, Gheuens S, Mehta L, Elkind MSV. Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2017 Mar;16(3):217-226. doi: 10.1016/S1474-4422(16)30357-X. Epub 2017 Feb 15.

Reference Type BACKGROUND
PMID: 28229893 (View on PubMed)

Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

Reference Type BACKGROUND
PMID: 29129157 (View on PubMed)

Zhang X, Zhao J, Sun Z, Wei D, Yao L, Li W, Zhu H, Liu W, Zhang H, Yuan X, Ma X, Meng J, Wang B, Jia Y, Qin N, Jiang W; MIST-A Study Group. Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective, randomised, open-label, blinded-endpoint trial. BMJ Open. 2024 Dec 20;14(12):e093443. doi: 10.1136/bmjopen-2024-093443.

Reference Type DERIVED
PMID: 39806586 (View on PubMed)

Other Identifiers

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XJLL-KY20222186

Identifier Type: -

Identifier Source: org_study_id

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