Acute Ischemic StrokePhase 3PEARL-TIRONCT07111806
Intravenous Tirofiban After Delayed Thrombolysis in Stroke
A Phase 3 study testing Tirofiban in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 852 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history;
- 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;
- 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%;
- Pre-stroke modified Rankin scale (mRS)≥2;
- Renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L [2.5 mg/dl]);
- Pregnant or lactating women;
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- NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS < 6;
- Allergy to tirofiban, other glycoprotein IIb/IIIa inhibitors, aspirin or clopidogrel;
- History of bleeding disorder, severe heart, liver or kidney disease, or sepsis;
- 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;
- CT or MR evidence of mass effect or intracranial tumor (except small meningioma);
- CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysm;
- 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;
- Participating in other clinical trials;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xinguang Yang contact
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Jinyuan Wang, 86-20-81332619, wangjy257@mail2.sysu.edu.cn
Xinguang Yang, yangxinguang0926@163.com
About this study
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
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).
Read the detailed description
This study is a multicenter, double-blind, double-dummy, randomized clinical trial designed to evaluate 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 primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.
Study intervention: (1) Participants in the intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach.
All participants will receive standard medical treatment.
A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban, Placebo
- Keywords
- Acute Ischemic Stroke, thrombolysis, Tirofiban
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Tirofiban is administered as a loading dose and continuous intravenous infusion as soon as possible after the randomization.
PlaceboDrug
Matched placebo will be infused in a similar fashion.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Experimental | Not described Receives: Drug: Tirofiban |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score (mRS) 0-1
The proportion of mRS score 0-1 at 90 (±14) days.
Measured: 90 (±14) days
Secondary outcomes (4)
Distribution of modified Rankin Scale score at 90 days
The shift analysis of the 90-day mRS with 5-6 merged at 90 (±14) days.
Measured: 90 (±14) days
The modified Rankin Scale score 0-2
The proportion of mRS score 0-2 at 90 (±14) days.
Measured: 90 (±14) days
Early neurological improvement
The proportion of patients with a ≥30% decrease in National Institute of Health stroke scale score from baseline.
Measured: 48 (±12) hours
Quality of life (EQ-5D-5L)
Health-related quality of life measured by EQ-5D-5L scale score at 90 (±14) days.
Measured: 90 (±14) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111806
- Sponsor's protocol ID
- PEARL-TIRO
- Acronym
- PEARL-TIRO
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from Principal Investigators (Prof. Yamei Tang) upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07111806
- Acronym / sponsor ID
- PEARL-TIRO / PEARL-TIRO
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, thrombolysis, Tirofiban
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is a multicenter, double-blind, double-dummy, randomized clinical trial designed to evaluate 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 primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.
Study intervention: (1) Participants in the intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach.
All participants will receive standard medical treatment.
A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban group | Experimental | Drug: Tirofiban |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history;
- 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;
- 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%;
- Pre-stroke modified Rankin scale (mRS)≥2;
- Renal insufficiency (glomerular filtration rate < 30 mL/min or serum creatinine > 220 μmol/L [2.5 mg/dl]);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirofibanTirofiban is administered as a loading dose and continuous intravenous infusion as soon as possible after the randomization. | Drug | Tirofiban group |
| PlaceboMatched placebo will be infused in a similar fashion. | Drug | Placebo group |
Primary outcome
The modified Rankin Scale score (mRS) 0-1
Time frame: 90 (±14) days
The proportion of mRS score 0-1 at 90 (±14) days.
4 secondary outcomes
Distribution of modified Rankin Scale score at 90 days
Time frame: 90 (±14) days
The modified Rankin Scale score 0-2
Time frame: 90 (±14) days
Early neurological improvement
Time frame: 48 (±12) hours
Quality of life (EQ-5D-5L)
Time frame: 90 (±14) days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Yes. The IPD will be available from Principal Investigators (Prof. Yamei Tang) upon reasonable request 6 months after the trial completion.
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A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinguang Yang contact
Yamei Tang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirofiban in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinyuan Wang (86-20-81332619, wangjy257@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score (mRS) 0-1 (time frame: 90 (±14) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.