Stroke drug boost: could tenecteplase finish the job?
NCT ID NCT07471282
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving a clot-busting drug called tenecteplase directly into the brain artery can help stroke patients who still have blocked blood flow after a standard clot removal procedure. About 344 adults with a major stroke will be randomly assigned to receive either the drug or a placebo. The goal is to see if the drug improves recovery and reduces 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)
- What this could lead to
- If it works, this could provide a better way to restore blood flow and improve recovery for stroke patients whose arteries aren't fully cleared by the standard procedure.
- What could go wrong
- This is a Phase 3 trial, but it's still early to know if the drug will be effective or safe. There is a risk of bleeding in the brain, and the results may not apply to all stroke types.
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 344 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
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; 2. Time from symptom onset or last known well to randomization within 24 hours; 3. Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery; 4. NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy; 5. Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments; 6. Pre-stroke mRS score ≤ 1; 7. ASPECTS score ≥ 6; 8. Post-mechanical thrombectomy status with 2b ≤ eTICI \< 3, and the operator has decided not to attempt further mechanical recanalization of the occluded vessel; 9. No more than 3 passes with the thrombectomy device; 10. Signed informed consent obtained from the patient or their legal guardian. Exclusion Criteria: 1. Contraindications to intravenous thrombolysis (excluding time-based criteria); 2. DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation; 3. Baseline NIHSS score not obtained; 4. Severe allergy or absolute contraindication to iodinated contrast media; 5. Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication; 6. Blood glucose \< 50 mg/dL (2.8 mmol/L) or \> 400 mg/dL (22.2 mmol/L); 7. Platelet count \< 50 × 10⁹/L, or APTT \> 40 s, or PT \> 15 s; 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or current use of oral anticoagulants with INR \> 1.7; 9. Severe renal failure, defined as serum creatinine \> 3.0 mg/dL (or 265.2 μmol/L) or glomerular filtration rate \[GFR\] \< 30 mL/min, or requiring hemodialysis or peritoneal dialysis; 10. Patient unlikely to complete the 90-day follow-up (e.g., no fixed address, palliative care patient, etc.); 11. Suspected vasculitis or septic embolism; 12. Suspected aortic dissection; 13. Pre-existing neurological or psychiatric disease that would interfere with the assessment of outcomes; 14. Pregnancy or lactation; 15. Current participation in another clinical trial that could interfere with this study; 16. Any other condition deemed by the investigator to make the patient unsuitable for participation or to pose a significant risk to the patient.
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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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The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next