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

Phase 3

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Intravenous thrombolysis plus placebo; Drug: Intravenous thrombolysis plus tirofiban

• Registration Number: NCT06134622
• Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China

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.

Study Timeline

• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2024-03-14
• Primary Completion: 2024-09-25
• Study Completion: 2024-12-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 832

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous thrombolysis plus placebo administration	Intravenous thrombolysis plus placebo	Patients will receive Intravenous thrombolysis and placebo (saline) administration
Intravenous thrombolysis plus tirofiban administration	Intravenous thrombolysis plus tirofiban	Patients will receive Intravenous thrombolysis and tirofiban administration

Primary Outcome Measures

Name	Time	Method
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)
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 36 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 36 hours or any hemorrhage leading to death.

Secondary Outcome Measures

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China; 🇨🇳 Hefei, Anhui, China