Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Jilin University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Drug: Tirofiban simulant; Drug: Tirofiban

Study type: Interventional

Funder types: Other

Identifiers

NCT06045156

ADVENT

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,084 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,084 participants in 2 patient groups, including a placebo group

Tirofiban group

Active Comparator group

Description:

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

Treatment:

Drug: Tirofiban

Tirofiban simulant group

Placebo Comparator group

Description:

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

Treatment:

Drug: Tirofiban simulant