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NCT Number: NCT06045156

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Yi Yang, MD, PhD

CONTACT

[email protected]

13756661217

About this study

Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.

Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years old;
  • Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
  • Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
  • Tirofiban or placebo treatment can be initiated within 6h after IVT;
  • mRS score before onset≤ 1;
  • Intracranial hemorrhage is ruled out by CT head after IVT;

Exclusion criteria

  • Received or plan to undergo bridge therapy;
  • Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
  • Atrial fibrillation or suspected cardiac embolism;
  • Accompanied by epileptic seizures;
  • Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
  • Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
  • Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
  • Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L;
  • Life expectancy less than 3 months;
  • Pregnant or lactating women;
  • Known allergy to tirofiban;
  • Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
  • Patients who are unwilling to be followed up or likely to have poor treatment compliance;
  • Other situations that the researcher deems unsuitable for inclusion in the study.

Treatment and study plan

tirofiban

Drug

Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation

Tirofiban simulant

Drug

Tirofiban simulant is placebo packed the same style as tirofiban

Primary outcomes

  1. Proportion of patients of modified Rankin Scale (mRS)≤1

    Time frame: 90±7 days

    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome

Secondary outcomes

  1. Proportion of patients of mRS≤2

    Time frame: 90±7 days

    mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome

  2. Distribution of mRS

    Time frame: 90±7 days

    mRS depicts functional outcome of stroke, which ranges from 0-6

  3. National Institute of Health stroke scale (NIHSS)

    Time frame: 24 hours after IVT, 7 days

    National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome

Other outcomes

  1. Symptomatic intracranial hemorrhage

    Time frame: within 24 hours of completion of study drug infusion, hospitalization

    Symptomatic intracranial hemorrhage is defined according to the ECASS Classification

  2. Hemorrhagic transformation

    Time frame: 24 hours after IVT, hospitalization

    defined according to the ECASS Classification

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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