Status:
COMPLETED
Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
Lead Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
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 a...
Eligibility Criteria
Inclusion
- Onset of ischemic stroke symptoms within ≤ 4.5 hours\*, treated with intravenous rt-PA or TNK according to guidelines;
- NIHSS score of 4-25 before intravenous thrombolysis;
- Age ≥ 18 years;
- Able to receive the designated study drug within 60 minutes after intravenous thrombolysis;
- Informed consent signed by the patient or their legal representative. \*Symptom onset is defined as the last known well time.
Exclusion
- Presence of contraindications to intravenous thrombolysis;
- Pre-stroke mRS score \> 1;
- Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
- Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation;
- Pregnant or lactating women;
- NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6;
- If NIHSS worsens by 2 or more points between start of thrombolysis and start of study drug, repeat brain imaging rules out new intracranial hemorrhage;
- Severe leukoaraiosis;
- Currently participating in other clinical trials;
- Known genetic or acquired bleeding diathesis, or received warfarin 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;
- Life expectancy \< 1 year;
- Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT06134622
Start Date
March 14 2024
End Date
December 30 2024
Last Update
May 4 2025
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001