Tirofiban Versus Placebo After Delayed Clot-Dissolving Treatment for Stroke
Tests tirofiban injection, compared with placebo, in adults with ischemic stroke.
Key facts
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Intravenous Tirofiban After Delayed Thrombolysis in Stroke
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 852 people, planned
- Started
- 1 Dec 2025
- Expected to end
- 1 Mar 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tirofiban
- Placebo
- Record updated
- 8 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had an ischemic stroke 4.5 to 24 hours ago and got clot-dissolving treatment (IVT). They must not have a blocked large or medium brain artery.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Acute ischemic stroke, last known well 4.5-24 hours before. After IVT, there is either no clear change or early worsening. NIHSS score of 4 or higher before randomization.
- Earlier treatment
- Must have received IVT (clot-dissolving treatment). Must be able to get the study drug within 60 minutes after IVT.
Main reasons for not taking part
- Bleeding in the brain, or any past bleeding in the brain
- Blocked large brain artery shown on vessel imaging
- Clear heart sources of clots, such as atrial fibrillation
- Severe kidney problems, or pregnant or breastfeeding
- Bleeding disorder, or taking a direct oral anticoagulant in the last 48 hours
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Aged 18 years or older
- Clinical diagnosed acute ischemic stroke (AIS) with last known well time of 4.5-24 hours
- Any of the following presentation of AIS:
- Treated with IVT followed by no significant change in neurological function; 2) Treated with IVT followed by early neurological deterioration; 4. NIHSS score ≥4 before randomization; 5. Able to receive the designated study drug within 60 minutes after IVT; 6. Written informed consent is obtained from patients and/or their legal representatives
Who cannot take part
- Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history
- Pre-stroke modified Rankin scale (mRS)≥2
- Allergy to tirofiban, other glycoprotein IIb/IIIa inhibitors, aspirin or clopidogrel
- History of bleeding disorder, severe heart, liver or kidney disease, or sepsis
- Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast
- Any terminal illness with life expectancy less than 6 months
- Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
- Renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L [2.5 mg/dl])
- Active bleeding diathesis, including clinical laboratory evidence of coagulation abnormalities (platelet count < 100×10⁹/L, activated partial thromboplastin time >50 seconds or international normalized ratio > 1.7), or treatment with a direct oral anticoagulant within the prior 48h
- CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1 or M2 segment, anterior cerebral artery A1 segment, and vertebrobasilar artery
- Pregnant or lactating women
- NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS < 6
- CT or MR evidence of mass effect or intracranial tumor (except small meningioma)
- CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysm
- Participating in other clinical trials
Where in China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Jinyuan WangNo longer taking part
About the trial
What the trial wants to find out
A multicenter, double-blind, double-dummy, randomized trial evaluating the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT).
The 2 groups in the trial
- Tirofiban groupTreatment being tested
Treatment: Tirofiban
- Placebo groupPlacebo, for comparison
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intravenous Tirofiban Versus Placebo After Delayed Thrombolysis (4.5-24h) in Acute Ischemic Stroke (PEARL-TIRO): A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial
- Plain-language title
- Tirofiban Versus Placebo After Delayed Clot-Dissolving Treatment for StrokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 August 2025