Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

NCT ID: NCT06045156

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1084 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2026-12-30

Brief Summary

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

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.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; intravenous thrombolysis; tirofiban

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tirofiban group

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

Group Type: ACTIVE_COMPARATOR

Tirofiban

Intervention Type: DRUG

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

Tirofiban simulant group

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

Group Type: PLACEBO_COMPARATOR

Tirofiban simulant

Intervention Type: DRUG

Tirofiban simulant is placebo packed the same style as tirofiban

Interventions

Tirofiban

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

Intervention Type: DRUG

Tirofiban simulant

Tirofiban simulant is placebo packed the same style as tirofiban

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yi Yang, MD, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38196129 (View on PubMed)

Other Identifiers

ADVENT

Identifier Type: -

Identifier Source: org_study_id