Intravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion (RESCUE-AS)

January 12, 2026 updated by: Liping Liu, Beijing Tiantan Hospital

Intravenous Tirofiban After Bridging Therapy for Acute Stroke With Atherosclerotic Large Artery Occlusion (RESCUE-AS): A Multicenter, Randomized, Open Label, Blinded Endpoint Study

The investigators propose to assess the efficacy and safety of intravenous tirofiban after bridging therapy (endovascular therapy [EVT] following intravenous Tenecteplase) for acute ischemic stroke due to intracranial atherosclerotic disease related large vessel occlusion (ICAD related LVO). This study will recruit 564 patients from about 50 hospitals in China. Inclusion criteria for the trial are: (1)age ≥18 years old, (2)Pre-mRS 0-2, (3)Baseline NIHSS 6-30 points, (4) Baseline ASPECTS ≥6 points, (5) Baseline CTA/MRA diagnosed: the ICA or MCA-M1/M2 occlusion, (6) Receiving bridging therapy (EVT following IV Tenecteplase) within 24 hours from stroke onset (7) Baseline DSA diagnosed: ICAD related LVO(if any one the following criteria is fulfilled: 1) absence of atrial fibrillation; 2) truncal-type occlusion; 3) residual stenosis ≥30% on DSA after the first retriever; 4) researchers determined it to be ICAD-related LVO based on the TOAST classification, (8) Have achieved successful reperfusion after EVT (mTICI ≥2b). Patients with previously known permanent, persistent, or paroxysmal atrial fibrillation, permanent stenting during EVT, severe bleeding or had a higher bleeding risk in the last 6 months, imaging examination before randomization showed the Heidelberg hemorrhage type 1c, 2, or 3 ICH with or without clinical exacerbation, infarct area greater than 50% of the middle cerebral artery blood supply area or infarct volume ≥70ml, cerebral hernia signs, and some other severe organic diseases and an expected survival time of less than 90 days, severe liver insufficiency or renal insufficiency will be excluded. Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental group will receive intravenous tirofiban of a dose of 0.4 μg/kilo/min for 30 minutes after the completion of bridging therapy, followed by a continuous infusion of 0.1 μg/kilo/min for up to 24 hours. Then the patient will transition to standard medical therapy, with no restrictions on the antiplatelet regimen but is advised to receive loading dose dual antiplatelet therapy (oral aspirin 100 mg and clopidogrel 300 mg four hours before the end of intravenous tirofiban and daily oral aspirin 100 mg and clopidogrel 75 mg for 30 days). Control group will receive standard medical therapy after bridging treatment. The primary endpoint is the proportion of modified Rankin Scale (mRS) score 0 to 2 at 90±7 days after onset. The primary safety outcome is the symptomatic intracerebral hemorrhage (sICH) within 48 hours after randomization according to ECASS III criteria. This trial will provide important information for the standardization of antiplatelet medication regimens after bridging therapy for improving functional outcomes in patients with acute large vessel atherosclerotic occlusive ischemic 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.
564

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 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.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old.
  2. Pre-mRS 0-2.
  3. Baseline NIHSS 6-30 points.
  4. Baseline ASPECTS ≥6 points.
  5. Baseline CTA/MRA diagnosed: the ICA or MCA-M1/M2 occlusion.
  6. Receiving bridging therapy (EVT following IV Tenecteplase) within 24 hours from stroke onset.

  7. Baseline DSA diagnosed: ICAD related LVO.

    * ICAD-related LVO is assumed if any one the following criteria is fulfilled: (1) absence of atrial fibrillation; (2) truncal-type occlusion; (3) residual stenosis ≥30% on DSA after the first retriever; (4) researchers determined it to be ICAD-related LVO based on the TOAST classification.

  8. Patients have achieved successful reperfusion after EVT (mTICI ≥2b).
  9. Patients or their eligible surrogates provided informed consent.

Exclusion Criteria:

  1. Previously known permanent, persistent, or paroxysmal atrial fibrillation.
  2. Permanent stenting during EVT;
  3. Patient had severe bleeding or the following conditions, such as active gastrointestinal ulcer, aortic dissection, platelet count <100 ×109/L, hemoglobin <100 g/L, INR≥1.7 in the last 6 months.
  4. Contraindication to glycoprotein IIb/IIIa inhibitors.
  5. Imaging examination (Flat-panel NCCT/DCT) before randomization showed the following: Heidelberg hemorrhage type 1c, 2, or 3 ICH with or without clinical exacerbation (an increase of ≥4 points in the NIHSS score from baseline or an increase of ≥2 points in any of the NIHSS scores or resulting in intubation, decompression of bone valves, ventricular drainage, or other significant medical/surgical intervention), infarct area greater than 50% of the middle cerebral artery blood supply area or infarct volume ≥70ml, cerebral hernia signs.
  6. Vascular malformations, arterial dissection, intracranial aneurysms, tumors (except for small meningiomas), cerebrovascular inflammation, cerebral amyloid angiopathy, or other major non-ischemic craniocerebral diseases (e.g. multiple sclerosis) as diagnosed by head imaging.
  7. Acute renal failure, dialysis, or estimated glomerular filtration rate (eGFR) < 30ml/min/1.72m2, or serum creatinine > 220mmol/L (2.5mg/dl).
  8. History of severe liver disease, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyltransferase (GGT) ≥3×ULN and/or total bilirubin (TBIL) ≥2×ULN.
  9. Acute ST elevation myocardial infarction (MI), acute decompensated heart failure, QTc>500 ms, hospitalization or involuntary coronary intervention due to acute coronary syndrome, MI, cardiac arrest within the past 3 months.
  10. Severe non-cardiovascular comorbidity with life expectancy < 3 months (e.g., malignant tumors).
  11. Any clinical conditions determined by the study team that may limit adherence to the study process.
  12. Currently receiving an investigational drug or device.
  13. Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test.
  14. The subject's informed consent was not obtained.

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: None (Open Label)

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.
Active Comparator: Control Group
Drug: Standard Medical Therapy
standard medical therapy after randomization. The antiplatelet regimen is not restricted.
Experimental: Tirofiban Group
Drug: Intravenous Tirofiban
Intravenous infusion of tirofiban within 5 minutes after randomization at a dose of 0.4 μg/kg/min for 30 minutes, followed by maintenance infusion via an intravenous microinfusion pump at 0.1 μg/kg/min for 23.5 hours (if tirofiban has already been administered intraoperatively, a continuous intravenous microinfusion pump at 0.1 μg/kg/min will be started directly postoperatively and continued for 24 hours). Tirofiban will be discontinued at 24 hours.

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
symptomatic intracerebral hemorrhage according to ECASS III criteria
Time Frame: within 48 hours after randomization
within 48 hours after randomization
the proportion of mRS score 0 to 2
Time Frame: at 90±7 days after onset
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance.
at 90±7 days after onset

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
Early reocclusion
Time Frame: within 48±12 hours after randomization
within 48±12 hours after randomization
Severe bleeding according to GUSTO criteria
Time Frame: within 48±12 hours after randomization
within 48±12 hours after randomization
Early neurological deterioration (increase in NIHSS score ≥4 points within 72 hours after randomization)
Time Frame: within 72±12 hours after randomization
within 72±12 hours after randomization
Any intracerebral hemorrhage
Time Frame: within 48±12 hours after randomization
within 48±12 hours after randomization
Mortality
Time Frame: within 90 days after onset
within 90 days after onset
Ordinal mRS score
Time Frame: at 90±7 days after onset
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.
at 90±7 days after onset
mRS score 0 to 1
Time Frame: at 90±7 days after onset
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities.
at 90±7 days after onset
mRS score 0 to 3
Time Frame: at 90±7 days after onset
The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance.
at 90±7 days after onset

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.
Beijing Tiantan Hospital

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.
January 12, 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.
January 31, 2027

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.
April 30, 2027

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).
January 5, 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.
January 5, 2026

First Posted (Estimated)

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.
January 12, 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.
January 13, 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.
January 12, 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.
January 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.
  • RESCUE-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available. Sharing IPD will require IRB approval from Tiantan Hospital and other participating institutes in China.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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