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 (INSTANT-2)

September 20, 2026 updated by: Zhongming Qiu, Xinqiao Hospital of Chongqing

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1482

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Guoyong Zeng, doctor
  • Phone Number: +8613507079530
  • Email: hsyygy@126.com

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China, 236600
        • Taihe County People's Hospital
    • Fujian
      • Longyan, Fujian, China, 364000
        • Longyan First Hospital of Fujian Medical University
    • Hunan
      • Xiangtan, Hunan, China, 411100
        • Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou People's Hospital
      • Ganzhou, Jiangxi, China, 342414
        • Xingguo People's Hospital, Xinguo Hospital of Gannan Medical University
      • Jingdezhen, Jiangxi, China, 333000
        • Jingdezhen First People's Hospital
      • Jingdezhen, Jiangxi, China, 341000
        • The First People's Hospital of Jingdezhen City
      • Jiujiang, Jiangxi, China
        • Jiujiang First People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Dalian Central Hospital
    • Sichuan
      • Mianyang, Sichuan, China, 621000
        • The First People's Hospital of Mianyang (Mianyang 404 Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. 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.
  3. 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.
  4. Written informed consent is obtained from the patient or legal representative.

Exclusion Criteria:

  1. Intracranial hemorrhage confirmed by CT or MRI after intravenous thrombolysis and prior to randomization.
  2. 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.
  3. History of atrial fibrillation or suspected cardioembolic stroke. Platelet count <100×10⁹/L on routine blood test.
  4. Renal insufficiency with estimated glomerular filtration rate (eGFR) <30 mL/min.
  5. Pregnant or breastfeeding women.
  6. Pre-existing neurological or psychiatric disorders that interfere with neurological function assessment.
  7. History of bleeding disorders, severe cardiac, hepatic or renal disease, or sepsis.
  8. Brain tumor with mass effect on imaging (excluding small meningioma). Intracranial aneurysm or arteriovenous malformation (AVM).
  9. Advanced illness with life expectancy less than 6 months.
  10. Current participation in another clinical trial.
  11. Other conditions deemed unsuitable for enrollment by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Tirofiban 24-hour group

Arm A: Patients receive tirofiban for 24 hours after intravenous thrombolysis.
Drug: Tirofiban Injection

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

Drug: Tirofiban Injection

Intravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 48 hours. The dosage regimen follows the trial protocol.
Experimental: Arm B: Tirofiban 48-hour group

Arm B: Patients receive tirofiban for 48 hours after intravenous thrombolysis.
Drug: Tirofiban Injection

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

Drug: Tirofiban Injection

Intravenous infusion of tirofiban will be initiated after intravenous thrombolysis and continued for 48 hours. The dosage regimen follows the trial protocol.
Active Comparator: Arm C: Standard care control group

No tirofiban is administered after intravenous thrombolysis.
Other: No Interventions

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 days after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mRS score at 90 days
Time Frame: 90 days after randomization

Modified Rankin Scale (mRS) score assessed at 90 days after randomization.
90 days after randomization
EQ-5D-5L score at 90 days
Time Frame: 90 days after randomization

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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 48 hours after randomization
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.
Within 48 hours after randomization
90-day mortality
Time Frame: 90 days after randomization

Proportion of participants who die within 90 days after randomization.
90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinqiao Hospital of Chongqing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Ganzhou Hospital of Nanchang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: zhongming qiu, Xinqiao Hospital of the Army Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INSTANT-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified cleaned individual participant data (IPD) will be shared upon reasonable request after publication of the primary study results. All personal identifiers will be removed to protect participant privacy.

IPD Sharing Time Frame

Available starting 6 months after publication of the primary manuscript.

IPD Sharing Access Criteria

Interested researchers may submit a formal research proposal and data access request to the corresponding author. The study steering committee will review each application.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings