Stroke treatment window could expand to 72 hours in new trial
NCT ID NCT06954155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the clot-busting drug tenecteplase can help people who have had a stroke 24 to 72 hours earlier. Currently, such drugs are only given within a few hours. The trial will compare tenecteplase to standard care (blood thinners) in 330 adults with blocked brain arteries. The goal is to see if more patients can 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
- Tenecteplase (a clot-busting drug given as a single injection)
- What this could lead to
- If it works, this could extend the time window for treating strokes from hours to days, helping more people recover with less disability.
- What could go wrong
- This is an early phase 3 trial with only 330 participants. The drug may not improve outcomes and carries a risk of bleeding in the brain.
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
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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 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
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: * 1)Age ≥ 18 years old; * 2)Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time'; * 3)Pre-stroke modified Rankin scale (mRS) score ≤1; * 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function); * 5)Neuroimaging: 1. Middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA, being responsible for signs and symptoms of acute ischemic stroke; 2. target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio \>1.2, and mismatch volume \>10mL); * 6)Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: * 1)Present as a significant low-density lesion on CT * 2)Allergy to tenecteplase * 3)Rapidly improving symptoms at the discretion of the investigator * 4)NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is 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 hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days * 8)Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an aPTT greater than the upper limit of normal * 9)Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included) * 10)Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm * 11)Any terminal illness such that the patient would not be expected to survive more than 1 year * 12)Unable to perform CTP or PWI * 13)Hypodensity in \>1/3 MCA territory on non-contrast CT for MCA occlusion, and pc-ASPECTS \<6 for BAO * 14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI * 15)Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion) * 16)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial * 17)Unlikely to adhere to the trial protocol or follow-up * 18)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 * 19)Participation in other interventional clinical trials within the previous 3 months
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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
1 site. 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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Beijing tiantan hospital
RECRUITINGBeijing, 100070, 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?
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