NCT07111806Not yet recruitingPhase 3
Intravenous Tirofiban After Delayed Thrombolysis in Stroke
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
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 852 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Stroke
- NCT number
- NCT07111806
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 852
- From 1 Dec 2025 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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;
Other
- 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;
Who the study is looking for
- 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:
- 1\) 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.