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

NCT07537933 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: IA-Tirofiban-2026-1012SWYX:NO. 2026-1012
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke; Large-vessel Occlusion; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of Participants with Modified Rankin Scale (mRS) 0-2 at 90±7 Days

  90±7 days

• Proportion of Participants with mRS 0-3 at 90±7 Days

  90±7 Days

• Symptomatic Intracranial Hemorrhage (sICH) within 48 Hours

  48 hours

• Any Intracranial Hemorrhage (ICH) within 48 Hours

  48 hours

• 90-Day All-Cause Mortality

  90±7 days

Study Arms (2)

Intra-arterial Tirofiban Treatment

EXPERIMENTAL

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

No Intra-arterial Tirofiban Treatment

NO INTERVENTION

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.

Interventions

Tirofiban DRUG

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).

Intra-arterial Tirofiban Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital, Affiliated to Shandong First Medical University

Jinan, Shandong, 250000, 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

• Qinjian Sun, MD

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Chen, MD

CONTACT

+86-68773274; chenwang@sph.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors are masked (blinded) to the treatment allocation, ensuring unbiased assessment of the primary and secondary outcomes. All other parties, including the investigators and care providers, are unmasked (open-label).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: For the Interventional Study Model, participants will be randomly assigned to one of two groups: Experimental Group: Receive intra-arterial tirofiban immediately after achieving complete recanalization (eTICI 2c-3). Control Group: No intra-arterial tirofiban administered.

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be made available 6 months after the completion of the trial.
• 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.

Locations

CN (1)