Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

Study Overview
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Brief Summary
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To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.

Detailed Description
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The standard treatment for acute ischemic stroke is intravenous thrombolysis to dissolve fibrin and restore blood flow. However, reocclusion of blood vessels and stroke progression remain challenges after this treatment.

Official Title
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Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Intravenous thrombolysis plus tirofiban
* Drug: Intravenous thrombolysis plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Onset of ischemic stroke symptoms ≤4;5 hours, treated with intravenous alteplase or tenecteplase according to guidelines; NIHSS score before intravenous thrombolysis ≤25; Age ≥18 and ≤80 years; Patient or legal representative signs an informed consent form. Exclusion Criteria: Presence of contraindications for intravenous thrombolysis; Pre-stroke mRS score >1; Patients undergoing mechanical thrombectomy or other intravascular treatments (e;g;, intra-arterial thrombolysis); Known history of atrial fibrillation or emergency electrocardiogram indicating atrial fibrillation; Pregnant or lactating women; NCCT, CTA source images, or MRI-DWI showing ASPECTS or PC-ASPECTS <6; Currently participating in other clinical trials; Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours; Severe renal failure, defined as serum creatinine >3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate [GFR] <30, or patients requiring hemodialysis or peritoneal dialysis; Liver dysfunction (ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal); Known allergy to tirofiban or other IIb/IIIa inhibitors; Expected lifespan <1 year; Patients unable to complete the 90-day follow-up (e.g., no fixed residence, overseas patients).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous thrombolysis plus tirofiban administration<br>Patients will receive Intravenous thrombolysis and tirofiban administration | Drug: Intravenous thrombolysis plus tirofiban<br>* Patients randomized to the Tirofiban group will receive continuous intravenous infusion of tirofiban for 24 hours: initial infusion of 0.4 μg/kg/min for 30 minutes followed by a continuous infusion of 0.1 μg/kg/min for up to 23.5 hours. The tirofiban placebo will be infused in a similar fashion.<br>|
| Active Comparator: Intravenous thrombolysis plus placebo administration<br>Patients will receive Intravenous thrombolysis and placebo (saline) administration | Drug: Intravenous thrombolysis plus placebo<br>* placebo (saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a modified Rankin Score of 0-1 | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a modified Rankin Score of 0-3 | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure | 
| Modified Rankin Score | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) | 90 (± 14 days) after procedure | 
| NIHSS score | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 24 hours after procedure | 
| mortality | (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100% | 90 (± 14 days) after procedure | 
| symptomatic intracerebral hemorrhage (ICH) | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death. | within 72 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tirofiban, intravenous thrombolysis