Could a Pre-Transfer clot buster boost stroke recovery?
NCT ID NCT07253181
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study looks at whether giving a clot-dissolving drug called Tenecteplase to stroke patients before they are moved to a hospital that can perform a clot-removal procedure improves their recovery. The trial involves 572 adults who had a stroke caused by a large blockage in the front part of the brain and who can be treated within 4.5 to 24 hours after symptoms began. The goal is to see if this early treatment leads to less disability compared to standard care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 572 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age of 18 years or older; * AIS symptom onset to treatment initiation within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke); * Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels; * Functionally independent (mRS 0-2) prior to stroke onset; * Baseline National Institute of Health Stroke Scale (NIHSS) of 6-25; * Intended to transfer to ECCs for EVT (patient transfer), or intended to transfer a neurointerventionalist from the ECC for EVT (physician transfer); * Written informed consent from patients or legally authorized representatives; * Neuroimaging: large vessel occlusion (ICA, M1, proximal M2) by MRA or CTA AND the target mismatch profile on computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP), defined as an ischemic core volume \<70mL, mismatch volume ≥15mL and mismatch ratio ≥1.8; Alternative neuroimaging (if CTP or MRP is technically inadequate or unavailable): An Alberta Stroke Program Early CT Score (ASPECTS) score ≥7 on NCCT or MRI scan; Exclusion Criteria: * Known hypersensitivity or allergy to any ingredients of Tenecteplase; * Intended to receive IVT as standard-of-care therapy; * Rapidly improving symptoms with NIHSS score \<6 before randomization; * Any contra-indication for IVT except for the time criterion; * Known hereditary or acquired hemorrhagic diathesis; * Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, INR \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48 hours; if on any full dose heparin/heparinoid within the last 24 hours; * Ischemic stroke or myocardial infarction in previous 3 months * Previous intracranial hemorrhage, active internal bleeding (gastrointestinal or urinary tract hemorrhage) in previous 3 months; * Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg); * Other serious, advanced or terminal illness with life expectancy less than 6 months; * Baseline blood glucose \<50mg/dl or \>400mg/dl; * Contraindication to imaging with contrast agents; * Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA or MRA (e.g. bilateral MCA occlusions, or an MCA and a basilar artery occlusion); * Extensive early ischemic change on non-contrast CT or MRI-DWI estimated to be \>1/3 MCA territory, or significant hypodensity outside the Tmax\>6s perfusion lesion that invalidates mismatch criteria (if patient is enrolled based on CT perfusion criteria); any CT or MRI findings indicative of a high risk of sICH related to potential intravenous tenecteplase treatment in the judgement of the investigator; * Evidence of intracranial tumor (mass effect), acute intracranial hemorrhage, or arteriovenous malformation; * Current participation in another investigational drug or device study; * Suspected endocarditis; * Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated Hospital of Shandong Second Medical University
RECRUITINGWeifang, Shandong, 261031, China
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Xuanwu Hospital Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Cancer patients face a hidden Second-Stroke threat, and 24 hospitals are mapping it
- Can tiny neural exosomes help the brain heal after a severe stroke?