Intravenous Tirofiban After Delayed Thrombolysis in Stroke

NCT07111806 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PEARL-TIRO
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; thrombolysis; Tirofiban

Outcome Measures

Primary Outcomes (1)

• The modified Rankin Scale score (mRS) 0-1

  The proportion of mRS score 0-1 at 90 (±14) days.

  90 (±14) days

Secondary Outcomes (4)

• Distribution of modified Rankin Scale score at 90 days

  90 (±14) days

• The modified Rankin Scale score 0-2

  90 (±14) days

• Early neurological improvement

  48 (±12) hours

• Quality of life (EQ-5D-5L)

  90 (±14) days

Other Outcomes (4)

• SAFETY OUTCOME: Symptomatic intracranial hemorrhage

  48 (±12) hours

• SAFETY OUTCOME: Any intracranial hemorrhage

  48 (±12) hours

• SAFETY OUTCOME: Major extracranial bleeding

  48 (±12) hours

Study Arms (2)

Tirofiban group

EXPERIMENTAL

Drug: Tirofiban

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tirofiban DRUG

Tirofiban is administered as a loading dose and continuous intravenous infusion as soon as possible after the randomization.

Tirofiban group

Placebo DRUG

Matched placebo will be infused in a similar fashion.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yamei Tang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinyuan Wang

CONTACT

86-20-81332619; wangjy257@mail2.sysu.edu.cn

Xinguang Yang

CONTACT

yangxinguang0926@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after the trial completion.
• Access Criteria: The IPD will be available from Principal Investigators (Prof. Yamei Tang) upon reasonable request.

Locations

CN (1)