Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Tirofiban; Drug: Tirofiban simulant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1084
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Phone Number: 13756661217; Email: doctoryangyi@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Received or plan to undergo bridge therapy;
2. Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
3. Atrial fibrillation or suspected cardiac embolism;
4. Accompanied by epileptic seizures;
5. Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
6. Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
7. Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
8. 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；
9. Life expectancy less than 3 months;
10. Pregnant or lactating women;
11. Known allergy to tirofiban;
12. Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
13. Patients who are unwilling to be followed up or likely to have poor treatment compliance;
14. Other situations that the researcher deems unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tirofiban group; Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT	Drug: Tirofiban; Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation
Placebo Comparator: Tirofiban simulant group; Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT	Drug: Tirofiban simulant; Tirofiban simulant is placebo packed the same style as tirofiban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients of modified Rankin Scale (mRS)≤1	mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients of mRS≤2	mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome	90±7 days
Distribution of mRS	mRS depicts functional outcome of stroke, which ranges from 0-6	90±7 days
National Institute of Health stroke scale (NIHSS)	National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome	24 hours after IVT, 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage is defined according to the ECASS Classification	within 24 hours of completion of study drug infusion, hospitalization
Hemorrhagic transformation	defined according to the ECASS Classification	24 hours after IVT, hospitalization

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Publications and helpful links

General Publications

• Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute ischemic stroke; tirofiban; intravenous thrombolysis
• 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: ADVENT

Drug and device information, study documents

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