Clinical trial NCT06134622: Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
Official title: Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: tirofiban
intravenous thrombolysis
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 832
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: 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 after this treatment.

Eligibility criteria: Inclusion Criteria:

1. Onset of ischemic stroke symptoms within ≤ 4.5 hours\*, treated with intravenous rt-PA or TNK according to guidelines;
2. NIHSS score of 4-25 before intravenous thrombolysis;
3. Age ≥ 18 years;
4. Able to receive the designated study drug within 60 minutes after intravenous thrombolysis;
5. Informed consent signed by the patient or their legal representative. \*Symptom onset is defined as the last known well time.

Exclusion Criteria:

1. Presence of contraindications to intravenous thrombolysis;
2. Pre-stroke mRS score \> 1;
3. Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
4. Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation;
5. Pregnant or lactating women;
6. NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6;
7. 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;
8. Severe leukoaraiosis;
9. Currently participating in other clinical trials;
10. 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;
11. 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;
12. Liver dysfunction (ALT \> 2 times the upper limit of normal or AST \> 2 times the upper limit of normal);
13. Known allergy to tirofiban or other IIb/IIIa inhibitors;
14. Life expectancy \< 1 year;
15. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).

Primary outcomes:
measure: a modified Rankin Score of 0-1
timeFrame: 90 (± 14 days) after procedure
measure: mortality
timeFrame: 90 (± 14 days) after procedure
measure: symptomatic intracerebral hemorrhage (ICH)
timeFrame: within 36 hours after procedure
Secondary outcomes:
measure: a modified Rankin Score of 0-3
timeFrame: 90 (± 14 days) after procedure
measure: Modified Rankin Score
timeFrame: 90 (± 14 days) after procedure
measure: NIHSS score
timeFrame: 24 hours after procedure
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: Anhui
Study officials:
References:
citation: Tao C, Liu T, Sun J, Zhu Y, Li R, Wang L, Zhang C, Song J, Jing X, Nguyen TN, Nogueira RG, Saver JL, Hu W. Advancing stroke safety and efficacy through early tirofiban administration after intravenous thrombolysis: The multicenter, randomized, placebo-controlled, double-blind ASSET IT trial protocol. Int J Stroke. 2025 Mar;20(3):373-377. doi: 10.1177/17474930241299666. Epub 2024 Nov 20.