Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion (IA-Tirofiban)

Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion

The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are:

Does immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events?

Researchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe.

Participants will:

Be enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke; Endovascular Treatment; Large-vessel Occlusion
• Intervention / Treatment: Drug: Tirofiban

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wang Chen, MD; Phone Number: +86-68773274; Email: chenwang@sph.com.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Shandong Provincial Hospital, Affiliated to Shandong First Medical University
      • Contact: Qinjian Sun, MD; Phone Number: +86-68773274; Email: qjsun@email.sdfmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥18 years; Last known well to arterial puncture within 0 to 24 hours; Preoperative imaging confirms anterior circulation large-vessel occlusion, including intracranial internal carotid artery occlusion or middle cerebral artery M1 or dominant M2 occlusion; Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 to 25; Baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on CT or DWI; Pre-stroke modified Rankin Scale (mRS) score ≤1; eTICI 2c to 3 complete recanalization achieved after mechanical thrombectomy, or spontaneous recanalization to eTICI 2c to 3 confirmed intraoperatively without further thrombectomy; Embolic occlusion with no residual fixed stenosis in the target vessel after thrombectomy; Written informed consent provided by the participant or legally authorized representative.

Exclusion Criteria:

Pregnancy or breastfeeding; Active bleeding within the previous month or known severe bleeding tendency; Major underlying disease with life expectancy <6 months, or inability in the investigator's judgment to complete follow-up; Participation in another interventional clinical trial; Use of oral anticoagulants within 48 hours before symptom onset with INR >1.7, or recent use of direct oral anticoagulants not meeting institutional cessation or testing requirements; Platelet count <50 × 10^9/L; Blood glucose <2.8 mmol/L or >22.2 mmol/L that cannot be corrected promptly Severe renal insufficiency, defined as eGFR <30 mL/min/1.73 m² or serum creatinine >2.5 mg/dL; Uncontrolled blood pressure, defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg despite treatment; Imaging evidence of intracranial hemorrhage, or presence of an intracranial aneurysm, arteriovenous malformation, brain tumor, or other lesion associated with high bleeding risk; Bilateral acute cerebral infarction or multiple intracranial arterial occlusions Intraoperative vessel rupture, dissection, contrast extravasation, or other severe complications requiring a change in the standard anticoagulation strategy; Need for balloon angioplasty, permanent stent placement, or planned initiation of antiplatelet or anticoagulation therapy within 24 hours after the procedure; More than 3 thrombectomy passes or puncture-to-recanalization time >90 minutes; Use of an intraoperative intravenous heparin bolus, excluding heparinized saline flush; Suspected embolic stroke due to infection or infectious endocarditis; Severe allergy to contrast agents or tirofiban.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-arterial Tirofiban Treatment; Participants in this arm will receive immediate intra-arterial tirofiban (0.5 mg) infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. The infusion will be administered over 10 minutes (1 mL/min) at the time of complete recanalization.	Drug: Tirofiban; Immediate intra-arterial tirofiban (0.5 mg) infusion administered after achieving eTICI 2c-3 complete recanalization in patients with acute ischemic stroke due to large-vessel occlusion. The infusion is delivered over 10 minutes (1 mL/min).
No Intervention: No Intra-arterial Tirofiban Treatment; Participants in this arm will receive no intra-arterial tirofiban infusion after achieving eTICI 2c-3 complete recanalization following endovascular thrombectomy. Standard care will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Modified Rankin Scale (mRS) Score 0-1 at 90±7 Days	The primary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90±7 days, indicating functional independence after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion	90±7 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days	The secondary outcome of this study is the proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90±7 days, indicating mild disability after treatment with intra-arterial tirofiban following mechanical thrombectomy for acute ischemic stroke due to large-vessel occlusion.	90±7 days
Proportion of Participants with mRS 0-3 at 90±7 Days	This secondary outcome measures the proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90±7 days, indicating moderate disability	90±7 Days
Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours	This secondary outcome evaluates the incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours after treatment.	48 hours
Any Intracranial Hemorrhage (ICH) within 48 Hours	This outcome measures the occurrence of any intracranial hemorrhage (ICH) within 48 hours following the intervention	48 hours
90-Day All-Cause Mortality	This secondary outcome evaluates the all-cause mortality rate at 90±7 days.	90±7 days
Early Neurological Improvement (≥10-point decrease in NIHSS) at 48 hours	Early neurological improvement is defined as a decrease of 10 or more points from baseline in the National Institutes of Health Stroke Scale (NIHSS) score at 48 hours after treatment. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment and a worse outcome.	48 hours
Health-Related Quality of Life at 90±7 Days	Health-related quality of life will be measured at 90±7 days using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Scores range from -0.39 to 1, with higher scores indicating better quality of life.	90±7 days

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Investigators: Principal Investigator: QinJian Sun, MD, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Aromatic; Amino Acids, Cyclic; Tyrosine; Tirofiban
• Other Study ID Numbers: IA-Tirofiban-2026-1012; SWYX:NO. 2026-1012 (Other Identifier: Biomedical Research Ethics Committee of Shandong Provincial Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be available from Principal Investigators (Prof. Qinjian Sun) upon reasonable request 6 months after the trial completion.
• IPD Sharing Time Frame: IPD will be made available 6 months after the completion of the trial.
• IPD Sharing Access Criteria: The IPD can be accessed by Principal Investigators (Prof. Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No