Clinical trial NCT06045156: Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke
Official title: Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
intravenous thrombolysis
tirofiban
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 1084
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
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.

Primary outcomes:
measure: Proportion of patients of modified Rankin Scale (mRS)≤1
timeFrame: 90±7 days
Secondary outcomes:
measure: Proportion of patients of mRS≤2
timeFrame: 90±7 days
measure: Distribution of mRS
timeFrame: 90±7 days
measure: National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours after IVT, 7 days
Other outcomes:
measure: Symptomatic intracranial hemorrhage
timeFrame: within 24 hours of completion of study drug infusion, hospitalization
measure: Hemorrhagic transformation
timeFrame: 24 hours after IVT, hospitalization
Locations:
city: Chang chun
country: China
facility: The first hospital of Jilin University
state: Jilin
Study officials:
References: