AzTrials
AzTrials

Ischemic Stroke, AcutePhase 3EMPHASISNCT05836740

Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke

A Phase 3 study testing Minocycline hydrochloride capsule in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 58 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke, Acute
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
1,724 participants
Where
58 sitesChina
Study dates
19 May 2023to 15 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18≤Age≤80 years old;
  • Patients with acute ischemic stroke confirmed by CT or MRI within 72 hours of onset;
  • 4≤NIHSS≤25, and Ia≤1;
  • First stroke or mRS 0-1 before the onset of current stroke;
  • Patients or his/her legal representatives are able to understand and sign the informed consent.

Who cannot join

  • History of pseudomembranous colitis or antibiotic-related colitis.
  • Allergic to tetracycline antibiotics or any component of the investigational drug.
  • Known to be resistant to other tetracyclines.
  • Took tetracycline antibiotics within previous one week.
  • Known community-acquired bacterial infection, such as pneumonia or urinary tract infection.
  • History of intracranial hemorrhagic diseases within previous 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.
Show all 16Show fewer
  • Intracranial tumors, vascular malformations and other intracranial space-occupying lesions.
  • Rare or unknown etiology of LVO, such as dissection and vasculitis.
  • Severe hepatic insufficiency, renal insufficiency or receiving dialysis before randomization for various reasons (Severe hepatic insufficiency was defined as ALT >3 times the upper limit of normal value or AST >3 times the upper limit of normal value; Severe renal insufficiency was defined as creatinine > 3.0 mg/dl [265.2 μmol/L] or glomerular filtration rate<30 ml/min/1.73m2).
  • Bleeding tendency (including but not limited to): platelet count <100×109/L; Administration of oral warfarin and INR>2; Administration of heparin within previous 48 hours and APTT≥35s; Hereditary bleeding disorders, such as hemophilia.
  • Received any of the following treatments within previous 3 months: systemic retinoic acid, androgen/antiandrogen therapy (e.g., anabolic steroids, andiolactone).
  • History of intracranial or spinal surgery within previous 3 months; History of therapeutical surgery or major physical trauma within previous 1 month.
  • Women of childbearing age who do not use effective contraception and have no negative pregnancy test records; Women during lactation and pregnancy.
  • Life expectancy of less than 6 months due to advanced stage of comorbidity.
  • Participated in other interventional clinical trials within previous 3 months.
  • Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

China58 sites

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014030

  • The Eighth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Shunyi Hospital

    Beijing, Beijing Municipality, 101300

  • Beijing Tiantan Hospital

    Beijing

  • Benxi Central Hospital

    Benxi, Liaoning, 117000

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130000

  • Shimen People's Hospital

    Changde, Hunan, 415300

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

  • Changzhou Wujin Traditional Chinese Medicine Hospital

    Changzhou, Jiangsu, 213100

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • The First People's Hospital of Chenzhou/The First Affiliated Hospital of Xiangnan University

    Chenzhou, Hunan, 423000

  • Chongqing Donghua Hospital

    Chongqing, Chongqing Municipality, 400032

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • Dengzhou People's Hospital

    Dengzhou, Henan, 474100

  • Ningjin People's Hospital

    Dezhou, 253400

  • Xinjiang Production and Construction Corps 13 Division Red Star Hospital

    Hami, Xinjiang, 839000

  • Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine

    Hangzhou, Zhejiang, 310000

  • The Sixth People's Hospital of Hengshui

    Hengshui, Hebei, 053000

  • Hengyang Central Hospital

    Hengyang, Hunan, 421002

  • Xiuwu People's Hospital

    Jiaozuo, Henan, 454350

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

  • Zouping City People's Hospital

    Jining, 256200

  • Yuci District People's Hospital

    Jinzhong, Shanxi, 030600

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121000

  • Jiujiang University Affiliated Hospital

    Jiujiang, Jiangxi, 332000

  • Jiyuan Chinese Medical Hospital

    Jiyuan, Henan, 459000

  • Liaocheng Central Hospital

    Liaocheng, Shandong, 252000

  • The Third People's Hospital of Liaocheng

    Liaocheng, Shandong, 252000

  • Guanxian People's Hospital

    Liaocheng, Shandong, 252500

  • Linfen Central Hospital

    Linfen, Shanxi, 041000

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

  • Mengjin People's Hospital

    Luoyang, Henan, 471100

  • Luoning People's Hospital

    Luoyang, Henan, 471700

  • Mengzhou People's Hospital

    Mengzhou, Henan, 454750

  • The Second Nanning People's Hospital

    Nanning, Guangxi, 530031

  • Rudong People's Hospital

    Nantong, Jiangsu, 226400

  • Nanle Zhongxing Hospital

    Puyang, Henan, 457400

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Shanghai Pudong New Area Gongli Hospital

    Shanghai, Shanghai Municipality, 200135

  • Sui Chinese Medical Hospital

    Shangqiu, Henan, 476900

  • Shenzhen Hospital, Southern Medical University

    Shenzhen, Guangdong, 518000

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518000

  • The Fourth Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei, 063000

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin Municipality, 130000

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300000

  • Xinjiang Production&Construction Corps Hospital

    Ürümqi, Xinjiang, 830002

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong, 264400

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wuhan No.1 Hospital

    Wuhan, Hubei, 430000

  • Xi'an International Medical Center Hospital

    Xi'an, Shannxi, 710000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000

  • Xingyang People's Hospital

    Zhengzhou, Henan, 450100

  • Biyang People's Hospital

    Zhumadian, Henan, 463000

  • Pingyu People's Hospital

    Zhumadian, Henan, 463400

  • Zibo Central Hospital

    Zibo, Shandong, 255000

Other trials in China

About this study

Official title: Efficacy and Safety of Minocycline in Patients With Moderate to Severe Acute Ischemic Stroke: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial

The aim of this study was to evaluate the efficacy and safety of Minocycline versus placebo in the treatment of patients with moderate to severe acute ischemic stroke.

Read the detailed description

The aim of this study was to evaluate the efficacy and safety of 4.5-days Minocycline versus placebo in patients with moderate to severe acute ischemic stroke within 72 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation and thrombo-inflammation at different time points in patients with moderate to severe acute ischemic stroke within 72 hours of onset.

The primary objective is to evaluate the effect of Minocycline in improving the level of mRS score to 0-1 in patients with moderate to severe acute ischemic stroke within 72 hours of onset.

The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants were interviewed at screening/baseline period, 24±2 hours, 6±1 days, 90±7 days after randomization, and when events occurred.

Being tested
Minocycline hydrochloride capsule, Placebo capsules of Minocycline hydrochloride capsules
Keywords
Ischemic Stroke, Minocycline
Medical subject headings
Ischemic Stroke, cyclopia sequence

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 groups in NCT05836740
Study groupRoleWhat they receive
Minocycline treatment groupActive comparatorMinocycline Hydrochloride Capsules (50 mg per capsule) The first dose should be given immediately after randomization (within 30 minutes); 200mg (4 capsules) for the first dose; Subsequently, 100mg (2 capsules) will be administered once every 12 hours, a total of 9 times (lasting 4.5 days; the subject with dysphagia will be administrated through a nasal feeding tube)
Receives: Drug: Minocycline hydrochloride capsule
Minocycline placebo-control groupPlacebo comparatorPlacebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline) The method of administration was the same as that of treatment 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.

  1. mRS score 0-1

    Modified Rankin Scale score.

    Measured: At 90±7 days after randomization.

Secondary outcomes (8)

  1. mRS score.

    Modified Rankin Scale score.

    Measured: At 90±7 days after randomization.

  2. Changes in NIHSS score compared with baseline score.

    NIHSS score

    Measured: At 24±1 hours and 6±1 days after randomization.

  3. Changes in hs-CRP level compared with baseline level.

    hs-CRP was examined to evaluate the level of systematic inflammation

    Measured: At 6±1 days after randomization.

  4. Early neurological deterioration.

    Early neurological deterioration was defined as any new neurological symptoms or signs that occur within several hours or days of onset, as well as the progression of existing neurological deficit symptoms or signs.

    Measured: At 24±2 hours and 6±1 days after randomization.

  5. Recurrent stroke.

    Recurrent stroke includes recurrent ischemic stroke and recurrent hemorrhagic stroke.

    Measured: At 90±7 days after randomization.

  6. Recurrent ischemic stroke.

    The condition of recurrent ischemic stroke.

    Measured: At 90±7 days after randomization.

  7. Combined vascular events.

    Combined vascular events referred to stroke, myocardial infarction, and vascular death.

    Measured: At 90±7 days after randomization.

  8. Quality of life (EQ-5D) score.

    Scores of EuroQol (Quality of life) -5 Dimensions.

    Measured: At 90±7 days after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start19 May 2023
  3. Primary completion20 May 2024
  4. Study completion15 Aug 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This trial was a prospective, randomized, multicenter, double-blind, placebo-controlled parallel trial. Participants were randomly assigned according to the ratio of the experimental group: control group =1:1.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836740
Sponsor's protocol ID
KY2023-007-01
Acronym
EMPHASIS
Status last verified
May 2025
First submitted
19 Apr 2023
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou M, Wang H, Zhu J, Chen W, Wang L, Liu S, Li Y, Wang L, Liu Y, Yin P, Liu J, Yu S, Tan F, Barber RM, Coates MM, Dicker D, Fraser M, Gonzalez-Medina D, Hamavid H, Hao Y, Hu G, Jiang G, Kan H, Lopez AD, Phillips MR, She J, Vos T, Wan X, Xu G, Yan LL, Yu C, Zhao Y, Zheng Y, Zou X, Naghavi M, Wang Y, Murray CJ, Yang G, Liang X. Cause-specific mortality for 240 causes in China during 1990-2013: a systematic subnational analysis for the Global Burden of Disease Study 2013. Lancet. 2016 Jan 16;387(10015):251-72. doi: 10.1016/S0140-6736(15)00551-6. Epub 2015 Oct 26.

    PubMed 26510778

  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PubMed 34487721

  • Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, Cohen G. Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012 Jun 23;379(9834):2364-72. doi: 10.1016/S0140-6736(12)60738-7. Epub 2012 May 23.

    PubMed 22632907

  • Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.

    PubMed 27673305

  • Tao C, Nogueira RG, Zhu Y, Sun J, Han H, Yuan G, Wen C, Zhou P, Chen W, Zeng G, Li Y, Ma Z, Yu C, Su J, Zhou Z, Chen Z, Liao G, Sun Y, Ren Y, Zhang H, Chen J, Yue X, Xiao G, Wang L, Liu R, Liu W, Liu Y, Wang L, Zhang C, Liu T, Song J, Li R, Xu P, Yin Y, Wang G, Baxter B, Qureshi AI, Liu X, Hu W; ATTENTION Investigators. Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1361-1372. doi: 10.1056/NEJMoa2206317.

    PubMed 36239644

  • Shi K, Tian DC, Li ZG, Ducruet AF, Lawton MT, Shi FD. Global brain inflammation in stroke. Lancet Neurol. 2019 Nov;18(11):1058-1066. doi: 10.1016/S1474-4422(19)30078-X. Epub 2019 Jul 8.

    PubMed 31296369

  • Yang JL, Yang YR, Chen SD. The potential of drug repurposing combined with reperfusion therapy in cerebral ischemic stroke: A supplementary strategy to endovascular thrombectomy. Life Sci. 2019 Nov 1;236:116889. doi: 10.1016/j.lfs.2019.116889. Epub 2019 Oct 11.

    PubMed 31610199

  • McGarry T, Biniecka M, Veale DJ, Fearon U. Hypoxia, oxidative stress and inflammation. Free Radic Biol Med. 2018 Sep;125:15-24. doi: 10.1016/j.freeradbiomed.2018.03.042. Epub 2018 Mar 27.

    PubMed 29601945

  • Stoll G, Nieswandt B. Thrombo-inflammation in acute ischaemic stroke - implications for treatment. Nat Rev Neurol. 2019 Aug;15(8):473-481. doi: 10.1038/s41582-019-0221-1. Epub 2019 Jul 1.

    PubMed 31263257

  • Kollikowski AM, Schuhmann MK, Nieswandt B, Mullges W, Stoll G, Pham M. Local Leukocyte Invasion during Hyperacute Human Ischemic Stroke. Ann Neurol. 2020 Mar;87(3):466-479. doi: 10.1002/ana.25665. Epub 2020 Jan 16.

    PubMed 31899551

  • El Amki M, Wegener S. Improving Cerebral Blood Flow after Arterial Recanalization: A Novel Therapeutic Strategy in Stroke. Int J Mol Sci. 2017 Dec 9;18(12):2669. doi: 10.3390/ijms18122669.

    PubMed 29232823

  • Bustamante A, Ning M, Garcia-Berrocoso T, Penalba A, Boada C, Simats A, Pagola J, Ribo M, Molina C, Lo E, Montaner J. Usefulness of ADAMTS13 to predict response to recanalization therapies in acute ischemic stroke. Neurology. 2018 Mar 20;90(12):e995-e1004. doi: 10.1212/WNL.0000000000005162. Epub 2018 Feb 14.

    PubMed 29444972

  • Sagris D, Papanikolaou A, Kvernland A, Korompoki E, Frontera JA, Troxel AB, Gavriatopoulou M, Milionis H, Lip GYH, Michel P, Yaghi S, Ntaios G. COVID-19 and ischemic stroke. Eur J Neurol. 2021 Nov;28(11):3826-3836. doi: 10.1111/ene.15008. Epub 2021 Jul 17.

    PubMed 34224187

  • Stein LK, Mayman NA, Dhamoon MS, Fifi JT. The emerging association between COVID-19 and acute stroke. Trends Neurosci. 2021 Jul;44(7):527-537. doi: 10.1016/j.tins.2021.03.005. Epub 2021 Apr 8.

    PubMed 33879319

  • Wichmann D, Sperhake JP, Lutgehetmann M, Steurer S, Edler C, Heinemann A, Heinrich F, Mushumba H, Kniep I, Schroder AS, Burdelski C, de Heer G, Nierhaus A, Frings D, Pfefferle S, Becker H, Bredereke-Wiedling H, de Weerth A, Paschen HR, Sheikhzadeh-Eggers S, Stang A, Schmiedel S, Bokemeyer C, Addo MM, Aepfelbacher M, Puschel K, Kluge S. Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Ann Intern Med. 2020 Aug 18;173(4):268-277. doi: 10.7326/M20-2003. Epub 2020 May 6.

    PubMed 32374815

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minocycline hydrochloride capsule in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 58 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mRS score 0-1 (time frame: At 90±7 days after randomization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836740, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in