New combo therapy aims to boost stroke recovery
NCT ID NCT07290751
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding the blood thinner tirofiban after standard clot-busting treatment helps people with acute ischemic stroke recover better. About 976 adults whose stroke symptoms don't improve enough within an hour of initial treatment will receive either tirofiban or a placebo for 24 hours. The goal is to see if more patients achieve functional independence at 90 days, while carefully monitoring for bleeding risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirofiban
- What this could lead to
- If it works, this could provide a new treatment option for stroke patients who don't improve enough after initial clot-busting therapy, potentially reducing long-term disability.
- What could go wrong
- This is a Phase 4 trial, but it's still testing a new combination approach. Tirofiban increases bleeding risk, including bleeding in the brain, which could offset any benefits. The results may not apply to all stroke patients.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 976 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
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. Pre-stroke modified Rankin Scale (mRS) score of 0-1. 3. Acute ischemic stroke symptoms within 4.5 hours of last known well time. 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4. 5. Poor neurological improvement 1 hour after intravenous thrombolysis, defined as NIHSS decrease \<2 points, or neurological worsening within 1 hour, defined as NIHSS increase ≥1 point. 6. Not planned for or not eligible for endovascular treatment. 7. Subject or legally authorized representative can provide written informed consent. Exclusion Criteria: 1. Evidence of intracranial hemorrhage on imaging before randomization. 2. Non-ischemic intracranial pathologies, such as vascular malformation, aneurysm, tumor, abscess, or demyelinating disease. 3. Large or medium vessel stenosis requiring thrombectomy or intra-arterial thrombolysis. 4. Contraindications to tirofiban, including but not limited to:Known hypersensitivity to tirofiban; Severe hepatic dysfunction (ALT \>2× ULN or AST \>2× ULN); Severe renal dysfunction (serum creatinine \>1.5× ULN); Advanced heart failure (NYHA class III-IV); Coagulation disorders or history of systemic bleeding; History of thrombocytopenia or neutropenia; Prior drug-induced hematologic disease or liver dysfunction; Leukopenia (\<2×10\^9/L) or platelet count \<100×10\^9/L. 5. Use of tirofiban or other GP IIb/IIIa inhibitors before randomization, or planned use of such agents after randomization. 6. Definite cardioembolic source, including but not limited to: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical prosthetic heart valves, infective endocarditis, history of intracardiac thrombus, myocardial infarction within 3 months, dilated cardiomyopathy, spontaneous left atrial echo contrast, or left ventricular ejection fraction \<30%. 7. Pregnancy or lactation. 8. Expected survival \<6 months. 9. Pre-existing neurological or psychiatric disorders that may interfere with outcome assessment. 10. Unlikely to complete 90-day follow-up.
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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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Beijing Anzhen Hospital,Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 101118, China
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- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can a stroke drug shrink brain damage after clot removal?
- Can a new drug boost recovery after stroke surgery?
- Can a swift Clot-Buster boost stroke recovery?
- AI could forecast stroke outcomes in real time