New combo therapy aims to boost stroke recovery

NCT ID NCT07290751

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 976 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Anzhen Hospital,Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101118, China

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