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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

564

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

January 12, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Intravenous Tirofiban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe