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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Intravenous thrombolysis plus tirofiban; Drug: Intravenous thrombolysis plus placebo

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 Type: Interventional
• Enrollment (Estimated): 832
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wei Hu, MD, PhD; Phone Number: +86 055162284313; Email: andinghu@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affiliated Hospital of University of Science and Technology of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Onset of ischemic stroke symptoms ≤4;5 hours, treated with intravenous alteplase or tenecteplase according to guidelines;
2. NIHSS score before intravenous thrombolysis ≤25;
3. Age ≥18 and ≤80 years;
4. Patient or legal representative signs an informed consent form.

Exclusion Criteria:

1. Presence of contraindications for intravenous thrombolysis;
2. Pre-stroke mRS score >1;
3. Patients undergoing mechanical thrombectomy or other intravascular treatments (e;g;, intra-arterial thrombolysis);
4. Known history of atrial fibrillation or emergency electrocardiogram indicating atrial fibrillation;
5. Pregnant or lactating women;
6. NCCT, CTA source images, or MRI-DWI showing ASPECTS or PC-ASPECTS <6;
7. Currently participating in other clinical trials;
8. Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
9. 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;
10. Liver dysfunction (ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal);
11. Known allergy to tirofiban or other IIb/IIIa inhibitors;
12. Expected lifespan <1 year;
13. Patients unable to complete the 90-day follow-up (e.g., no fixed residence, overseas patients).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous thrombolysis plus tirofiban administration; Patients will receive Intravenous thrombolysis and tirofiban administration	Drug: 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.
Active Comparator: Intravenous thrombolysis plus placebo administration; Patients will receive Intravenous thrombolysis and placebo (saline) administration	Drug: Intravenous thrombolysis plus placebo; placebo (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a modified Rankin Score of 0-1	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)	90 (± 14 days) after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS score	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.	24 hours after procedure
mortality	(Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%	90 (± 14 days) after procedure
symptomatic intracerebral hemorrhage (ICH)	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 72 hours or any hemorrhage leading to death.	within 72 hours after procedure
a modified Rankin Score of 0-3	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)	90 (± 14 days) after procedure
Modified Rankin Score	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)	90 (± 14 days) after procedure

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: tirofiban; intravenous thrombolysis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: ASSET-IT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No