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

University of Science and Technology of China (USTC)

Status and phase: Completed; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Drug: Intravenous thrombolysis plus tirofiban; Drug: Intravenous thrombolysis plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06134622

ASSET-IT

Details and patient eligibility

About

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

Full 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.

Enrollment: 832 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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832 participants in 2 patient groups

Intravenous thrombolysis plus tirofiban administration

Experimental group

Description:

Patients will receive Intravenous thrombolysis and tirofiban administration

Treatment:

Drug: Intravenous thrombolysis plus tirofiban

Intravenous thrombolysis plus placebo administration

Active Comparator group

Description:

Patients will receive Intravenous thrombolysis and placebo (saline) administration

Treatment:

Drug: Intravenous thrombolysis plus placebo