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Completed

NCT Number: NCT06134622

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

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Hefei, Anhui, 230001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.).

Treatment and study plan

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 placebo

Drug

placebo (saline)

Primary outcomes

  1. a modified Rankin Score of 0-1

    Time frame: 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)

  2. mortality

    Time frame: 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%

  3. symptomatic intracerebral hemorrhage (ICH)

    Time frame: 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 outcomes

  1. a modified Rankin Score of 0-3

    Time frame: 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)

  2. Modified Rankin Score

    Time frame: 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)

  3. NIHSS score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: ASSET-IT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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