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

NCT06134622 | Completed Phase 3 DMC

• 1 other identifier: ASSET-IT
• Study Type: interventional
• Target: 832
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

tirofiban; intravenous thrombolysis

Outcome Measures

Primary Outcomes (3)

• 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

• 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 36 hours or any hemorrhage leading to death.

  within 36 hours after procedure

Secondary Outcomes (3)

• a modified Rankin Score of 0-3

  90 (± 14 days) after procedure

• Modified Rankin Score

  90 (± 14 days) after procedure

• NIHSS score

  24 hours after procedure

Study Arms (2)

Intravenous thrombolysis plus tirofiban administration

EXPERIMENTAL

Patients will receive Intravenous thrombolysis and tirofiban administration

Drug: Intravenous thrombolysis plus tirofiban

Intravenous thrombolysis plus placebo administration

ACTIVE COMPARATOR

Patients will receive Intravenous thrombolysis and placebo (saline) administration

Drug: Intravenous thrombolysis plus placebo

Interventions

Intravenous thrombolysis plus tirofiban 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 tirofiban administration

Intravenous thrombolysis plus placebo DRUG

placebo (saline)

Intravenous thrombolysis plus placebo administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230001, China

Location

Related Publications (2)

• 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.

  PMID: 39501470 RESULT

• Tao C, Liu T, Cui T, Liu J, Li Z, Ren Y, Zhao X, Xie F, Li J, Wang H, Huang L, Li J, Wen J, Zeng J, Zhu J, Li Z, Li D, Hu X, Huang B, Wang J, Zhang C, Ye B, Hou Y, Gan Y, Sun H, Guan F, Shao Y, Liu Z, Ou Z, Fan S, Wang Y, Zhai H, Ni C, Wang H, Zhang C, Zhao Y, Wang G, Zhu Y, Li R, Sun J, Hu H, Cui J, Wang L, Zhang C, Song J, Jing X, Wang A, Wang J, Xu P, Qureshi AI, Nguyen TN, Nogueira RG, Saver JL, Hu W; ASSET-IT Investigators. Early Tirofiban Infusion after Intravenous Thrombolysis for Stroke. N Engl J Med. 2025 Sep 25;393(12):1191-1201. doi: 10.1056/NEJMoa2503678. Epub 2025 Jul 4.

  PMID: 40616232 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized, double-blind trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: March 14, 2024
• Primary Completion: September 25, 2024
• Study Completion: December 30, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)