New stroke combo could boost recovery for medium clots
NCT ID NCT07137832
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests whether adding a clot-dissolving medicine directly into the brain's arteries during standard clot-removal procedures helps people recover better after a stroke caused by a medium-sized blockage. About 530 adults with acute ischemic stroke will be randomly assigned to receive either the standard treatment alone or the standard treatment plus the extra medicine. The main goal is to see if more people can live independently (score 0 or 1 on a disability scale) 90 days after the stroke.
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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 530 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 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: 1. Aged 18 years or older. 2. Clinical diagnosis of acute ischemic stroke. 3. CT angiography (CTA) or MR angiography (MRA) confirmed primary isolated medium vessel occlusion (i.e. an occlusion of the co-/non-dominant M2, the M3/M4 segment of the MCA, the A1/A2/A3 segment of the ACA, or the P1/P2/P3 segment of the PCA). 4. Baseline NIHSS ≥6. 5. Treatment (arterial puncture) can be initiated 5.1 Within 6 hours of last known well (LKW) OR 5.2 Within 6 to 24 hours of LKW AND evidence of salvageable brain tissue on CT perfusion or perfusion-diffusion MRI (ischemic core volume \<50mL, hypo-perfused tissue volume to ischemic core volume ratio \>1.4, mismatch volume \>10mL). Hypo-perfused tissue is defined as Tmax \>6s on CT perfusion or perfusion MRI. Ischemic core is defined as rCBF \<30% on CT perfusion or ADC \<620μm2/s on diffusion MRI. 6. Signed informed consent. Exclusion Criteria: 1. Evidence of intracranial hemorrhage. 2. Pre-stroke mRS score ≥ 2. 3. Rapidly improving symptoms, in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \<6 at randomization. 4. The intervention procedure is unlikely to be completed as assessed by the investigator. 5. Suspected cerebral vasculitis, septic embolization, or vascular occlusion due to infective endocarditis. 6. Suspected arterial dissection. 7. Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast. 8. Known genetic or acquired bleeding disposition or anticoagulant factors deficiency. 9. Coagulation disorder with INR \>1.7 or use of new oral anticoagulants within 48 hours prior to symptom onset. 10. Platelet count \<50×10\^9/L. 11. Any active or recent bleeding (gastrointestinal, urinary tract bleeding, etc.), or previous parenchymal organ surgery or biopsy in the last 1 month. 12. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, refractory to treatment. 13. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl). 14. Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma). 15. Anticipated life expectancy \<6 months due to advanced disease (e.g., malignancy, severe cardiopulmonary disease, etc.). 16. Women who are pregnant or breastfeeding. 17. Participation in other clinical trials. 18. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
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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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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510000, 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?