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

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Summary

NIH registered a Phase 3 clinical trial (NCT07537933) to evaluate whether immediate intra-arterial tirofiban after complete recanalization improves recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. The trial will enroll approximately 520 participants and compare tirofiban treatment with no tirofiban, measuring good functional outcome at 90 days and symptomatic intracranial hemorrhage risk. Primary completion is expected April 17, 2026.

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What changed

NIH ClinicalTrials.gov registered a new Phase 3 clinical trial (NCT07537933) titled 'Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion.' The trial will study tirofiban, a glycoprotein IIb/IIIa inhibitor, administered intra-arterially immediately after mechanical thrombectomy achieves complete recanalization in acute ischemic stroke patients. Approximately 520 adult participants will be randomly assigned to receive tirofiban or no tirofiban, with 90-day functional outcomes and bleeding event safety endpoints.

Pharmaceutical companies supplying tirofiban for investigational use, clinical investigators conducting the stroke trial, and institutional review boards overseeing human subjects research should note the trial registration. The study focuses on anterior circulation large-vessel occlusion, which represents a significant subset of acute ischemic stroke cases amenable to endovascular treatment. Sites should ensure investigational drug accountability, protocol compliance, and adverse event reporting align with IND requirements.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

Phase 3 NCT07537933 Kind: PHASE3 Apr 17, 2026

Abstract

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

Interventions: Tirofiban

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Last updated

Classification

Agency
NIH
Published
April 17th, 2024
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537933
Docket
NCT07537933

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical research Drug therapy Stroke treatment
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Medical Devices

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