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Could a second Clot-Buster boost stroke recovery?

NCT ID NCT05856851

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether giving the clot-busting drug alteplase directly into the brain artery, right after a mechanical thrombectomy has reopened a blocked vessel, can improve recovery from acute ischemic stroke. The study enrolls adults with large-vessel blockages in the front part of the brain, within 24 hours of symptom onset. Participants are randomly assigned to receive either standard care or standard care plus intra-arterial alteplase. The main goal is to see if more people achieve a good functional outcome (able to live independently) at 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
alteplase (a clot-busting drug) given directly into the artery after mechanical thrombectomy
What this could lead to
If effective, this could improve functional recovery and reduce disability for people who have had a major ischemic stroke, potentially changing standard post-thrombectomy care.
What could go wrong
This is a phase 3 trial, but results are not yet known. Adding a clot-buster after successful reopening of the vessel may increase bleeding risk in the brain, and benefits may not outweigh risks for all 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

324 people

The number who actually took part.

Started

Aug 2023

Finished

Nov 2025

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. Aged 18 years or older. 2. Clinical diagnosis of acute ischemic stroke. 3. Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to "Last Known Well" (LKW). 4. CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study. 5. Baseline NIHSS of 6-25. 6. NCCT/DWI-MRI ASPECTS ≥ 6; 7. Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness). 8. Signed informed consent. Exclusion Criteria: 1. Contraindication to rt-PA (except time to therapy). 2. Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy. 3. Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure. 4. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation. 5. Women who are pregnant or breastfeeding. 6. Participation in other clinical trials. 7. Preoperative intracranial hemorrhage confirmed by cranial CT or MRI. 8. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency. 9. Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset). 10. Platelet count \<50X10\^9/L. 11. Suspected vascular occlusion as a result of infective endocarditis. 12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl). 13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast. 14. Suspected aortic dissection. 15. Previous parenchymal organ surgery or biopsy in the last 1 month; 16. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month; 17. SBP \> 185 mmHg or DBP \> 110 mmHg refractory to treatment. 18. Anticipated life expectancy \< 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.). 19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, China

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120, China

More trials for these conditions

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