Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

NCT06045156 | Recruiting DMC

• 1 other identifier: ADVENT
• Study Type: interventional
• Target: 1,084
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; intravenous thrombolysis; tirofiban

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of patients of mRS≤2

  90±7 days

• Distribution of mRS

  90±7 days

• National Institute of Health stroke scale (NIHSS)

  24 hours after IVT, 7 days

Other Outcomes (2)

• Symptomatic intracranial hemorrhage

  within 24 hours of completion of study drug infusion, hospitalization

• Hemorrhagic transformation

  24 hours after IVT, hospitalization

Study Arms (2)

Tirofiban group

ACTIVE COMPARATOR

Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT

Drug: Tirofiban

Tirofiban simulant group

PLACEBO COMPARATOR

Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT

Drug: Tirofiban simulant

Interventions

Tirofiban DRUG

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

Tirofiban group

Tirofiban simulant DRUG

Tirofiban simulant is placebo packed the same style as tirofiban

Tirofiban simulant group

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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38196129 DERIVED

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: April 29, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)