Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Tirofiban simulant; Drug: Tirofiban

• Registration Number: NCT06045156
• Lead Sponsor: The First Hospital of Jilin University

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.

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Study Start: 2024-04-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2026-01-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1084

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;
7. Systolic blood pressure before enrollment≤ 160mmHg;

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients of mRS≤2	90±7 days	mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome
Distribution of mRS	90±7 days	mRS depicts functional outcome of stroke, which ranges from 0-6
National Institute of Health stroke scale (NIHSS)	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

Trial Locations

Locations (1)

The first hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China