New hope for stroke patients: drug may restore function after medium vessel blockages
NCT ID NCT07047014
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 caused by a medium-sized blood vessel blockage in the brain. About 600 participants will receive either tenecteplase or standard care within 4.5 to 24 hours of symptoms starting. The goal is to see if the drug improves recovery and reduces disability at 90 days.
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 596 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 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 within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time"; * (3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke; * (4)Neuroimaging criteria: a) Perfusion criteria:Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70mL, mismatch ratio \>1.2, mismatch volume \>10mL); b) If neither MRI or CT perfusion is available at the site : an Alberta Stroke Program Early CT Score \[ASPECTS\] of 8 or more on NCCT /MRI-DWI or PC-ASPECTS of 8 or more on NCCT/MRI-DWI. * (5)Pre-stroke modified Rankin scale (mRS) score ≤1; * (6)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms; * (7)Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: * (1)Allergy to tenecteplase; * (2)Rapidly improving symptoms at the discretion of the investigator; * (3)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; * (4)Intention to undergo endovascular treatment. * (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 dabigatran can be achieved with idarucizumab; 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 or hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO); * (14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI; * (15)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial; * (16)Unlikely to adhere to the trial protocol or follow-up; * (17) 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
7 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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Beijing tiantan hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100070, China
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Hai'an People's Hospital
RECRUITINGNantong, Jiangsu, 226600, China
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Jiuquan city people's hospital
RECRUITINGJiuquan, Gansu, 736100, China
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Jiyuan Traditional Chinese Medicine Hospital
RECRUITINGJiyuan, Henan, 459000, China
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The First Affiliated Hospital, School of Medicine, Zhejiang University
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310003, China
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The first people hospital of lingbao
RECRUITINGLingbao, Henan, 472500, China
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Xingtang People's Hospital
RECRUITINGShijiazhuang, Hebei, 050600, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stroke's hidden heart rhythm clue under investigation
- After a stroke, does the heart inflame? MRI study probes the link
- Natural capsule tested as Add-On for stroke recovery
- Can a drug infused into brain arteries protect stroke patients during clot removal?
- Can a Clot-Busting drug help stroke patients treated later?
- Can computer training rewire the brain to restore sight after stroke?