Stroke drug may work hours later than thought
NCT ID NCT05752916
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a clot-busting drug called rhTNK-tPA can help people having a stroke when given 4.5 to 24 hours after symptoms begin. It included 570 adults with a stroke that did not involve a large blocked artery. The goal was to see if the drug leads to better recovery (less disability) at 90 days compared to standard antiplatelet therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA)
- What this could lead to
- If it works, this could extend the time window for clot-busting treatment in stroke patients, allowing more people to recover with less disability.
- What could go wrong
- This is a completed Phase 4 trial, but results are not yet published. The drug may not improve outcomes beyond standard care and carries a risk of bleeding.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
570 people
The number who actually took part.
- Started
-
Jun 2023
- 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 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: * Clinical diagnosis of acute ischemic stroke * Age≥18 years * Pre-stroke mRS score≤1 points * Disabling stroke defined as follows: * Baseline NIHSS score 6-25 at the time of randomization, * Or NIHSS 4-5 with disabling deficit (e.g. hemianopia, aphasia, loss of hand function) as determined by the managing clinician * Onset (last-seen-well) time to treatment time between 4.5 and 24 hours * Written informed consent from patients or legally responsible representatives * The presence of a Target Mismatch on CT perfusion: ischemic core volume\<50ml (defined as rCBF\<30%), mismatch ratio≥1.2 (Tmax\>6 sec lesion/core volume lesion), mismatch volume≥10ml Exclusion Criteria: * Treatment with a thrombolytic within the last 72 hours or intention to receive intravenous thrombolysis * Contraindication to thrombolysis * Planned or anticipated treatment with endovascular therapy * Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in a NIHSS score\<4 at randomization * Pregnancy or lactating; formal testing needed in women of childbearing potential * Brain tumor (with mass effect) * Hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency * Impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, international normalized ratio (INR) \>1.7 or prothrombin time \>15s; if use of any direct oral anticoagulant within the last 48 hours; if use of heparin/heparinoid within the last 24 hours * Use of glycoprotein Ⅱb-Ⅲa inhibitors within the last 72 hours * Baseline platelet count \<100,000/μL * Undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency with glomerular filtration rate \<30ml/min or serum creatinine \>220mmol/L (2.5mg/dl) * Suspected aortic dissection * Major surgery or biopsy within the last 1 month * Any active bleeding within the previous 1 month (including gastrointestinal or urinary bleeding) * Known severe, life-threatening allergy (more severe than skin rash) to contrast agents * Severe, uncontrolled hypertension (systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg) * Any terminal illness such that the patient would not be expected to survive more than half a year * Current participation in any investigational study that may confound outcome assessment of the study * Any condition that, in the judgement of the investigator, is inappropriate for participation in the trial or could impose hazards to the patient (e.g. inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders) Specific Neuroimaging Exclusion Criteria: * Evidence of acute intracranial hemorrhage * Acute large vessel occlusion on magnetic resonance/ computed tomography angiography, including internal carotid artery (ICA), middle cerebral artery M1 segment (MCA-M1), vertebral artery and basilar artery
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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.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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