New combo therapy could boost stroke recovery
NCT ID NCT05797792
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding a clot-busting drug (alteplase) directly into the brain artery during mechanical clot removal improves recovery for people with severe stroke. About 440 participants with large vessel blockages will be randomly assigned to receive the drug or not. The main goal is to see if more patients are disability-free 90 days later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alteplase (a clot-busting drug given directly into the brain artery)
- What this could lead to
- If it works, this could become a standard add-on treatment to improve outcomes for people having a major stroke, potentially reducing long-term disability.
- What could go wrong
- This is an early-stage trial with 440 participants, so results may not apply to all stroke patients. Adding a clot-buster 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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440 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Nov 2025
- 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: * Patients with symptomatic large vessel occlusion (LVO) in the anterior circulation (ICA, ACA or MCA) treated with MT resulting in a mTICI score 2b/3 at end of the procedure. Patients with a mTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study. * Estimated delay to onset of rescue intraarterial rt-PA administration \<24 hours from symptom onset, defined as the point in time the patient was last seen well. * No significant pre-stroke functional disability (modified Rankin scale 0-1), or mRS \>1 that according to the investigator is not related to neurological disease (i.e., amputation, blindness) * Age ≥18 * ASPECTS \>6 on non-contrast CT (NCCT) scan if symptoms lasting \<4.5 hours of last seen well. In patients with \>4.5h of last seen well, a CT-perfusion (Flow maps) or MRI-perfusion should be considered instead of NCCT, especially if \>9h have elapsed, or in seriously ill patients (i.e., NIHSS\>17). Nonetheless, if a perfusion study is not available, NCCT can still be used as long as it is confirmed without a doubt that the ASPECTS is \> 6. * Informed consent, obtained from patient or acceptable patient surrogate, or Differed Informed Consent (DIC) to avoid any delay in the initiation of the mechanical thrombectomy and the i.a thrombolysis. The DIC will be signed by the patient or acceptable patient surrogate at any time after the tPA treatment is started. Exclusion Criteria: * NIHSS score on admission \>25 * Contraindication to IV t-PA as per local national guidelines (except time to therapy) * Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h * Need of more than 3 passes (per vessel) or more than a total of 5 passes (in more than one vessel) to complete the endovascular procedure * Female who is pregnant or lactating or has a positive pregnancy test at time of admission * Current participation in another investigation drug or device treatment study * Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency * Known coagulopathy, INR \> 1.7 * Platelets \< 50,000 * Renal Failure as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \< 30 * Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason * Any hemorrhage on CT/MRI * Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal * Suspicion of aortic dissection * Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol * History of life-threatening allergy (more than rash) to contrast medium * SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment * Serious, advanced, terminal illness with anticipated life expectancy \< 6 months * Pre-existing neurological or psychiatric disease that would confound evaluation * Presumed vasculitis or septic embolization * Unlikely to be available for 90-day follow-up (i.e., no fixed home address, visitor from overseas)
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Genom att skicka in godkänner du våra Användarvillkor
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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Hospital Clinic Barcelona
Barcelona, Spain, 08014, Spain
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Hospital Germans Trías i Pujol
Badalona, Spain, Spain
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Hospital Josep Trueta
Girona, Spain, Spain
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Hospital Universitario Central de Asturias
Oviedo, Spain, Spain
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Hospital Universitario Dr. Balmis
Alicante, Spain, Spain
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Hospital Universitario Son Espases
Palma de Mallorca, Spain, Spain
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Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, Spain
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Hospital Universitario de A Coruña
A Coruña, Spain, Spain
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Hospital Universitario de Cruces
Bilbao, Spain, Spain
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Hospital Universitario de Donostia
San Sebastián, Spain, Spain
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Hospital Universitario de Navarra
Pamplona, Spain, Spain
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Hospital Universitario de Valladolid
Valladolid, Spain, Spain
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Hospital Univesitario y Politénico La Fe
Valencia, Spain, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, Spain
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