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Could early aspirin boost stroke recovery? new trial investigates

NCT ID NCT06548971

Disease control Sponsor: Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving aspirin within 3 hours of clot-busting treatment for stroke can improve recovery without causing dangerous bleeding. About 1,184 adults who had an ischemic stroke will receive either aspirin or a placebo. The goal is to see if early aspirin leads to better function after 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin
What this could lead to
If it works, this could change guidelines to allow earlier aspirin after stroke treatment, potentially preventing further damage and improving recovery.
What could go wrong
This is a phase 3 trial, but early aspirin may increase the risk of bleeding in the brain. The results may not apply to all stroke patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,184 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years old; 2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis. 3. Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization. 4. Informed consent obtained from patients or an authorized representative. Exclusion Criteria: 1. Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery, intracranial/extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by vessel imaging (including computed tomography angiography \[CTA\] or magnetic resonance angiography \[MRA\]), or scheduled for endovascular treatment (including mechanical thrombectomy, intra-arterial thrombolysis, and angioplasty). 2. Intracranial hemorrhage confirmed by imaging post-thrombolysis. 3. Definite or suspected cardioembolic stroke. 4. Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders. 5. Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)\>1.7. 6. Prior history of moderate or severe ischemic stroke events with residual neurological disability. 7. Pre-stroke mRS score \> 1. 8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points. 9. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area. 10. Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding 11. History of aspirin allergy. 12. Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state) 13. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 mL/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]), severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \>2 times the upper limit of normal, or serum aspartate aminotransferase \[AST\] \>2 times the upper limit of normal), severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV) 14. Severe non-cardiovascular complications with an expected survival of less than 6 months. 15. Unavailability for follow-up. 16. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up. 17. Current participation in another therapeutic study with ongoing treatment and follow-up. 18. Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.

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Conditions

The condition(s) this trial relates to.

cerebral infarction ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Cerebral infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aerospace central hospital

    RECRUITING

    Haidian, Beijing Municipality, 100049, China

  • Affiliated Hospital of Inner Mongolia University for the Nationalities

    RECRUITING

    Tongliao, Inner Mongolia, 028007, China

  • Anshan Changda hospital

    NOT_YET_RECRUITING

    Anshan, Liaoning, 114000, China

  • Beijing Luhe Hospital affiliated to Capital Medical University

    RECRUITING

    Tongzhou, Beijing Municipality, 101149, China

  • Beijing Pinggu District Hospital

    RECRUITING

    Pinggu, Beijing Municipality, 101200, China

  • Brain Hospital Affiliated to Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Cangzhou Central Hospital

    RECRUITING

    Cangzhou, Hebei, 061012, China

  • Cangzhou combination of Chinese traditional and western medicine hospital

    RECRUITING

    Cangzhou, Hebei, 061001, China

  • Changde Taoyuan County People's Hospital

    NOT_YET_RECRUITING

    Changde, Hunan, 415099, China

  • Chengdu Second People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Chenzhou first people's hospital

    NOT_YET_RECRUITING

    Chenzhou, Hunan, 424499, China

  • Donggang city Central Hospital

    RECRUITING

    Dandong, Liaoning, 118300, China

  • Dongying people's hospital

    RECRUITING

    Dongying, Shandong, 257029, China

  • First People's Hospital of Luoyang

    RECRUITING

    Luoyang, Henan, 471000, China

  • Fujian university affiliated provincial hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Fushun Mining Bureau General Hospital

    NOT_YET_RECRUITING

    Fushun, Liaoning, China

  • Gaotang county people's hospital

    RECRUITING

    Liaocheng, Shandong, 252800, China

  • Guigang people's hospitalv

    RECRUITING

    Guigang, Guangxi, 537100, China

  • Haiyan People's Hospital

    RECRUITING

    Jiaxing, Zhejiang, 314311, China

  • Handan Central Hospital

    RECRUITING

    Handan, Hebei, 056001, China

  • Handan first hospital

    RECRUITING

    Handan, Hebei, 056002, China

  • Hejian city People's Hospital

    RECRUITING

    Cangzhou, Hebei, 062450, China

  • Hua county People's Hospital

    RECRUITING

    Anyang, Henan, 456400, China

  • Huanghe Sanmenxia hospital

    NOT_YET_RECRUITING

    Sanmenxia, Henan, 472000, China

  • Jiaozuo Second People's Hospital

    RECRUITING

    Jiangzuo, Henan, 454001, China

  • Jinan Third People's Hospital

    RECRUITING

    Jinan, Shandong, 250101, China

  • Jingdezhen NO.1 People's Hospital

    RECRUITING

    Jingdezhen, Jiangxi, 333000, China

  • Jun county people's hospital

    RECRUITING

    Hebi, Henan, 458030, China

  • Juxian county people's hospital

    RECRUITING

    Rizhao, Shandong, 276500, China

  • Liaocheng people's hospital

    RECRUITING

    Liaocheng, Shandong, 252000, China

  • Liuyang Jili Hospital

    RECRUITING

    Guankou, Hunan, 410300, China

  • Luoyang Yanshi People's Hospital

    RECRUITING

    Luoyang, Henan, 471900, China

  • Luyi county people's hospital

    RECRUITING

    Zhoukou, Henan, 477200, China

  • Nanyang nanshi hospital

    NOT_YET_RECRUITING

    Nanyang, Henan, 473010, China

  • Ningling county people's hospital

    RECRUITING

    Shangqucun, Henan, 476700, China

  • Pingdu city traditional Chinese medicine hospital

    RECRUITING

    Qingdao, Shandong, 266700, China

  • Rizhao traditional Chinese medicine hospital

    RECRUITING

    Rizhao, Shandong, 276800, China

  • Shandong health group feicheng hospital

    RECRUITING

    Taian, Shandong, 271614, China

  • Shandong province qianfoshan hospital

    RECRUITING

    Jinan, Shandong, 250014, China

  • Shangqiu First People's Hospital

    RECRUITING

    Shangqiu, Henan, 476100, China

  • Shangqiu Third People's Hospital

    RECRUITING

    Shangqiu, Henan, 476000, China

  • Shengli oilfield central hospital

    RECRUITING

    Dongying, Shandong, 257034, China

  • Shenzhen Second People's Hospital

    RECRUITING

    Shenzhen, Shenzhen, 518035, China

  • Shihezi City People's Hospital

    RECRUITING

    Shihezi, Xinjiang, 832000, China

  • Suzhou municipal hospital

    RECRUITING

    Suzhou, Anhui, 234000, China

  • The First Affiliated Hospital Of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215004, China

  • The First Hospital Of Qiqihar

    RECRUITING

    Qiqihar, Heilongjiang, 161005, China

  • The First People's Hospital of Changde City

    RECRUITING

    Changde, Hunan, 415000, China

  • The Fourth Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215021, China

  • The Second Affiliated Hospital Of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330008, China

  • The Second Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Kaili, Guizhou, 556099, China

  • The Second Affiliated Hospital of Hainan Medical University

    RECRUITING

    Haikou, Hainan, 570145, China

  • The Third People Hospital In Liaocheng

    RECRUITING

    Liaocheng, Shandong, 252000, China

  • The Third People's Hospital of Hubei Province

    RECRUITING

    Hainan, Hubei, 430033, China

  • The Third The People's Hospital Of Bengbu

    RECRUITING

    Bengbu, Anhui, 233000, China

  • Togtoh county hospital

    RECRUITING

    Neimeng, Neimeng, 010200, China

  • Ulanqab Central Hospital

    RECRUITING

    Ulanqab, Inner Mongolia, 012000, China

  • Weihai Municipal Hospital

    RECRUITING

    Weihai, Shandong, 264200, China

  • Weinan central hospital

    NOT_YET_RECRUITING

    Weinan, Shanxi, 714000, China

  • Wuzhou Red Cross Hospital

    RECRUITING

    Wuzhou, Guangxi, 543002, China

  • Xiamen Xinglin hospital

    NOT_YET_RECRUITING

    Xiamen, Fujian, 361020, China

  • Xiangtan Central Hospital

    RECRUITING

    Xiangtan, Hunan, 411100, China

  • Xihua People's Hospital

    RECRUITING

    Zhoukou, Henan, 466000, China

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Ya 'an People's Hospital

    RECRUITING

    Ya'an, Sichuan, 625000, China

  • Zha Lan Tun Shi Zhong Meng Yi Yuan

    RECRUITING

    Zhalantun, Inner Mongolia, 162650, China

  • Zhangzhou Hospital of Fujian Province

    RECRUITING

    Zhangzhou, Fujian, 363000, China

  • Zhumadian Central Hospital

    RECRUITING

    Zhumadian, Henan, 463000, China

  • Zhuzhou Central Hospital

    RECRUITING

    Zhuzhou, Hunan, 412007, China

  • Zibo Central Hospital

    NOT_YET_RECRUITING

    Zibo, Shandong, 255020, China

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Other studies related to the condition(s) this trial covers.