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New study tests if adding a Clot-Buster before mechanical stroke treatment boosts recovery

NCT ID NCT06221371

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 391 people with a type of stroke caused by a blockage in a major brain artery, treated 4.5 to 24 hours after symptoms started. Half got a clot-busting drug called tenecteplase followed by a mechanical clot removal procedure, while the other half had the procedure alone. The goal was to see if adding the drug leads to better recovery and less disability 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: Tenecteplase (a clot-busting drug given intravenously)
What this could lead to: If successful, this could show that adding tenecteplase before a mechanical clot removal procedure improves recovery for people with late-window stroke.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The benefit of adding tenecteplase may be small or outweighed by bleeding risks, and findings 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

391 people

The number who actually took part.

Started

Jan 2024

Finished

Oct 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. Age≥18 years old; 2. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment including wake-up stroke and unwitnessed stroke; onset time refers to 'last seen well time'; 3. MCA-M1 or proximal M2 occlusions confirmed by Computer Tomography Angiography (CTA)/Magnetic Resonance Angiography (MRA) that was responsible for signs and symptoms of acute ischemic stroke; 4. Neuroimaging: target mismatch profile on CT perfusion (CTP) or MRI + MR perfusion imaging (MRP) (analyzed by perfusion analysis software with Class II and above medical device certificates) \[ischemic core volume (defined as CBF\<30% or apparent diffusion coefficient value \< 620×10-6 mm2/s) \<70mL, mismatch ratio≥1.8, mismatch volume≥15mL\]; 5. Pre-morbid mRS score ≤2; 6. Baseline NIHSS 6-25 (both included); 7. Written informed consent from patients or their legally authorized representative. Exclusion criteria 1. Patients who decline interventional therapy or intravenous thrombolysis (IVT)； 2. Patients allergic to tenecteplase； 3. Rapidly improving symptoms at the discretion of the investigators； 4. NIHSS consciousness score 1a\>2, or epileptic seizure, hemiplegia after seizures or combined with other nervous/mental illness not able to cooperate or unwilling to cooperate； 5. Persistent blood pressure elevation (systolic \> 185 mmHg or diastolic \>110 mmHg), despite blood pressure lowering treatment； 6. Blood glucose \< 2.8 or \> 22.2 mmol/L (point of care glucose testing is acceptable)； 7. Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days； 8. Any known impairment in coagulation, e.g.: If on vitamin K antagonists, then INR \>1.7 or prothrombin time \>15 seconds; if use of any direct thrombin inhibitors or new oral anticoagulants (NOACs) during the last 48 hours unless reversal of effect can be achieved with idarucizumab; values in sensitivity laboratory tests exceed the upper limit of normal \[including activated partial thromboplastin time (APTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assays, etc.\]; if on heparin during the last 24 hours or with an elevated aPTT greater than the upper limit of normal； 9. Known defect of platelet function or platelet count below 100\*109/L (patients on antiplatelet agents can be included)； 10. Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury, intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm (excluding neuroectodermal tumors such as meningioma), arteriovenous malformation or giant aneurysm； 11. Patients who would not be expected to survive more than 1 year； 12. Unable to perform CTP or MRP； 13. Large infarct on non-contrast CT brain or MRI (infarct size \>1/3 MCA territory)； 14. Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid haemorrhage, and subdural / extradural hematoma； 15. Multiple arterial occlusions (bilateral MCA occlusion, MCA occlusion accompanied by basilar artery occlusion)； 16. Pregnant women, nursing mothers, or reluctant to take contraceptive measures during the trial period； 17. Unlikely to adhere to the trial protocol or follow-up； 18. Any condition that, in the investigator's judgment, could pose a hazard to the patient if study therapy is initiated or could impact the patient's ability to participate in the study； 19. Participation in any other interventional clinical trials within the previous 3 months.

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Conditions

The condition(s) this trial relates to.

ischemic stroke middle cerebral artery infarction

As listed by the trial registrant

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

Endovascular treatment Ischemic stroke, acute Thrombolysis

Contacts and locations

Locations

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China
Dalian Municipal Central Hospital

Dalian, Liaoning, China
First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China
First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China
First People's Hospital of Chenzhou

Chenzhou, Hunan, 423000, China
Heze Municipal Hospital

Heze, Shandong, 274400, China
Jining NO.1 People's Hospital

Jining, Shandong, China
Liaocheng Third People's Hospital

Liaocheng, Shandong, 252006, China
Linyi Central Hospital

Linyi, Shandong, China
Linyi People's Hospital

Linyi, Shandong, 276003, China
People's Hospital of Queshan

Zhumadian, Henan, China
Puyang Oilfield General Hospital

Puyang, Henan, China
Qingdao Central Hospital

Qingdao, Shandong, 266000, China
Rizhao People's Hospital

Rizhao, Shandong, 276800, China
Rizhao Traditional Chinese Medicine Hospital

Rizhao, Shandong, 276800, China
The 2nd affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China
The First Affiliated Hospital of USTC

Hefei, Anhui, China
Weifang People's Hospital

Weifang, Shandong, China
Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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