Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
Study Details
Study Description
Brief Summary
To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravenous thrombolysis plus tirofiban administration Patients will receive Intravenous thrombolysis and tirofiban administration |
Drug: Intravenous thrombolysis plus tirofiban
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.
|
| Active Comparator: Intravenous thrombolysis plus placebo administration Patients will receive Intravenous thrombolysis and placebo (saline) administration |
Drug: Intravenous thrombolysis plus placebo
placebo (saline)
|
Outcome Measures
Primary Outcome Measures
- a modified Rankin Score of 0-1 [90 (± 14 days) after procedure]
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)
Secondary Outcome Measures
- a modified Rankin Score of 0-3 [90 (± 14 days) after procedure]
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)
- Modified Rankin Score [90 (± 14 days) after procedure]
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)
- NIHSS score [24 hours after procedure]
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.
- mortality [90 (± 14 days) after procedure]
(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
- symptomatic intracerebral hemorrhage (ICH) [within 72 hours after procedure]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Onset of ischemic stroke symptoms ≤4;5 hours, treated with intravenous alteplase or tenecteplase according to guidelines;
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NIHSS score before intravenous thrombolysis ≤25;
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Age ≥18 and ≤80 years;
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Patient or legal representative signs an informed consent form.
Exclusion Criteria:
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Presence of contraindications for intravenous thrombolysis;
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Pre-stroke mRS score >1;
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Patients undergoing mechanical thrombectomy or other intravascular treatments (e;g;, intra-arterial thrombolysis);
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Known history of atrial fibrillation or emergency electrocardiogram indicating atrial fibrillation;
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Pregnant or lactating women;
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NCCT, CTA source images, or MRI-DWI showing ASPECTS or PC-ASPECTS <6;
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Currently participating in other clinical trials;
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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;
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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;
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Liver dysfunction (ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal);
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Known allergy to tirofiban or other IIb/IIIa inhibitors;
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Expected lifespan <1 year;
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Patients unable to complete the 90-day follow-up (e.g., no fixed residence, overseas patients).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | China | 230001 |
Sponsors and Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASSET-IT