Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07842185

A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Duration of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke

Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis.

This is a multicenter, three-arm, open-label, endpoint-blinded randomized controlled trial. A total of 1482 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group, or blank control group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.

Not yet recruiting

Trial opening soon.

Get Notified

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 2 / Phase 3

Primary location

Taihe County People's Hospital, Fuyang, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of acute ischemic stroke meeting the diagnostic criteria from Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023, and the patient has received intravenous thrombolysis with tenecteplase, alteplase or reteplase.
  • Disabling stroke remains at 2-24 hours after completion of intravenous thrombolysis. Disabling stroke is defined as NIHSS score ≥ 4, or single limb motor subscore ≥ 2.
  • Written informed consent is obtained from the patient or legal representative.

Exclusion criteria

  • Intracranial hemorrhage confirmed by CT or MRI after intravenous thrombolysis and prior to randomization.
  • CTA/MRA/DSA demonstrates occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, anterior cerebral artery, or vertebrobasilar artery.
  • History of atrial fibrillation or suspected cardioembolic stroke. Platelet count <100×10⁹/L on routine blood test.
  • Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min.
  • Pregnant or breastfeeding women.
  • Pre-existing neurological or psychiatric disorders that interfere with neurological function assessment.
  • History of bleeding disorders, severe cardiac, hepatic or renal disease, or sepsis.
  • Brain tumor with mass effect on imaging (excluding small meningioma). Intracranial aneurysm or arteriovenous malformation (AVM).
  • Advanced illness with life expectancy less than 6 months.
  • Current participation in another clinical trial.
  • Other conditions deemed unsuitable for enrollment by the investigator.

Treatment and study plan

Tirofiban Injection

Drug

Intravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 24 hours. The dosage regimen follows the trial protocol.

No interventions

Other

No tirofiban will be administered after intravenous thrombolysis. Patients receive routine standard clinical management according to hospital guidelines.

Primary outcomes

  1. Proportion of patients with mRS 0-1 at 90 days

    Time frame: 90 days after randomization

    Percentage of participants achieving modified Rankin Scale (mRS) score 0 or 1 at 90 days after randomization.

Secondary outcomes

  1. mRS score at 90 days

    Time frame: 90 days after randomization

    Modified Rankin Scale (mRS) score assessed at 90 days after randomization.

  2. EQ-5D-5L score at 90 days

    Time frame: 90 days after randomization

    EQ-5D-5L questionnaire score assessed at 90 days after randomization.

  3. Proportion of patients with mRS 0-2 at 90 days

    Time frame: 90 days after randomization

    Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 2 at 90 days after randomization.

  4. Proportion of patients with mRS 0-3 at 90 days

    Time frame: 90 days after randomization

    Percentage of participants achieving modified Rankin Scale (mRS) score 0 to 3 at 90 days after randomization.

  5. Proportion of early neurological improvement

    Time frame: 48 hours after randomization

    Percentage of participants with early neurological improvement, defined as ≥30% reduction in NIHSS score at 48 hours post-randomization compared with the NIHSS score at randomization.

Other outcomes

  1. Incidence of symptomatic intracranial hemorrhage (sICH) within 48 hours

    Time frame: Within 48 hours after randomization

    Proportion of participants with symptomatic intracranial hemorrhage (sICH) within 48 hours after randomization, defined by the Heidelberg criteria.

  2. Incidence of any intracranial hemorrhage (any ICH) within 48 hours

    Time frame: Within 48 hours after randomization

    Proportion of participants with any intracranial hemorrhage (any ICH) within 48 hours after randomization.

  3. 90-day mortality

    Time frame: 90 days after randomization

    Proportion of participants who die within 90 days after randomization.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

  • The Affiliated Ganzhou Hospital of Nanchang University

Registry information

Official study title

A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Infusion Duration of Early Tirofiban Treatment After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke (INSTANT-2)

Acronym: INSTANT-2

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.