Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Sponsor

The First Hospital of Jilin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045156

Collaborator

(none)

1,084

Enrollment

Arms

35.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Tirofiban Drug: Tirofiban simulant	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1084 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 30, 2026

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Symptomatic intracranial hemorrhage [within 24 hours of completion of study drug infusion, hospitalization]
Symptomatic intracranial hemorrhage is defined according to the ECASS Classification
Hemorrhagic transformation [24 hours after IVT, hospitalization]
defined according to the ECASS Classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
Systolic blood pressure before enrollment≤ 160mmHg;

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.