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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2024-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

randomized, double-blind trial

Study Groups

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Intravenous thrombolysis plus tirofiban administration

Patients will receive Intravenous thrombolysis and tirofiban administration

Group Type EXPERIMENTAL

Intravenous thrombolysis plus tirofiban

Intervention Type DRUG

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.

Intravenous thrombolysis plus placebo administration

Patients will receive Intravenous thrombolysis and placebo (saline) administration

Group Type ACTIVE_COMPARATOR

Intravenous thrombolysis plus placebo

Intervention Type DRUG

placebo (saline)

Interventions

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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.

Intervention Type DRUG

Intravenous thrombolysis plus placebo

placebo (saline)

Intervention Type DRUG

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No