NCT06265051

Brief Summary

Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,380

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

February 9, 2024

Last Update Submit

March 8, 2026

Conditions

Acute Ischemic StrokeVessel Occlusion

Keywords

mechanical thrombectomyacute ischemic strokesuccessful recanalizationtirofiban

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients functionally independent (mRS score 0 to 2) at 90 days

    independent outcome at 90 days

    90 days after randomization

  • Number of participants with symptomatic intracranial hemorrhage

    According to Heidelberg Bleeding Classification

    within 48 hours of randomization

Secondary Outcomes (7)

  • Modified ranking scale (mRS)

    90 days after randomization

  • Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1)

    90 days after randomization

  • Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3)

    90 days after randomization

  • Number of participants with improvement of neurological function

    36 hours (24-48 hours) after randomization

  • Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L)

    90 days after randomization

  • +2 more secondary outcomes

Study Arms (2)

Tirofiban group

EXPERIMENTAL

After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery.

Drug: Tirofiban

placebo group

PLACEBO COMPARATOR

After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the control group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery.

Drug: Saline placebo

Interventions

TirofibanDRUG

After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery.

Also known as: trade name: Xinweining; Wuhan Grand Pharmaceutical Group Co., LTD. (China)
Tirofiban group
Saline placeboDRUG

After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery.

placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old;
  • NIHSS score: 6-30;
  • Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.
  • mRS 0-1 before the stroke;
  • Subject or legal representative can sign an informed consent form;
  • Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;
  • ASPECTS≥6 on NCCT or DWI;
  • After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.

You may not qualify if:

  • Intra-arterial thrombolysis;
  • Tirofiban was used within 24 hours before endovascular treatment
  • Women who are known to be pregnant or lactating, or have a positive pregnancy test before randomization;
  • Allergy to tirofiban, radiocontrast agent or Nitinol materials;
  • Any active bleeding within 30 days before stroke or recent bleeding (gastrointestinal, urinary, etc.);
  • parenchymal organ surgery or biopsy within 14 days before stroke;
  • History of heparin-induced thrombocytopenia;
  • Platelet count \< 100\*10\^9/L;
  • Being on hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate \&lt; 30ml/min or serum creatinine \&gt; 220μmol/L).
  • Subjects requiring hemodialysis or peritoneal dialysis or who have contraindications to angiography for any reason;
  • The expected survival time is less than half a year (such as malignant tumors, serious heart and lung diseases, etc.);
  • Have participated in other interventional clinical studies that may have an impact on the outcome assessment;
  • Other circumstances that the investigator considers inappropriate for participation in the study or that may pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorder).
  • The midline shift of the brain or cerebral hernia, ventricular mass effect;
  • Acute intracranial hemorrhage on CT or MRI;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 450001, China

Location

Related Publications (5)

  • Renu A, Millan M, San Roman L, Blasco J, Marti-Fabregas J, Terceno M, Amaro S, Serena J, Urra X, Laredo C, Barranco R, Camps-Renom P, Zarco F, Oleaga L, Cardona P, Castano C, Macho J, Cuadrado-Godia E, Vivas E, Lopez-Rueda A, Guimaraens L, Ramos-Pachon A, Roquer J, Muchada M, Tomasello A, Davalos A, Torres F, Chamorro A; CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645.

    PMID: 35143603BACKGROUND

  • Dornbos D 3rd, Katz JS, Youssef P, Powers CJ, Nimjee SM. Glycoprotein IIb/IIIa Inhibitors in Prevention and Rescue Treatment of Thromboembolic Complications During Endovascular Embolization of Intracranial Aneurysms. Neurosurgery. 2018 Mar 1;82(3):268-277. doi: 10.1093/neuros/nyx170.

    PMID: 28472526BACKGROUND

  • Guan Q, Yun W, Li X, Ni H, Lv W, Xie Z, Zhang L, Zhou J, Xu Y, Li J, Zhang Q. Association of tirofiban with improvement of functional outcomes of direct thrombectomy for acute anterior circulation occlusion: a retrospective, nonrandomized, multicenter, real-world study. Neurosurg Focus. 2023 Oct;55(4):E21. doi: 10.3171/2023.7.FOCUS23150.

    PMID: 37778035BACKGROUND

  • RESCUE BT Trial Investigators; Qiu Z, Li F, Sang H, Luo W, Liu S, Liu W, Guo Z, Li H, Sun D, Huang W, Zhang M, Zhang M, Dai W, Zhou P, Deng W, Zhou Z, Huang X, Lei B, Li J, Yuan Z, Song B, Miao J, Liu S, Jin Z, Zeng G, Zeng H, Yuan J, Wen C, Yu Y, Yuan G, Wu J, Long C, Luo J, Tian Z, Zheng C, Hu Z, Wang S, Wang T, Qi L, Li R, Wan Y, Ke Y, Wu Y, Zhu X, Kong W, Huang J, Peng D, Chang M, Ge H, Shi Z, Yan Z, Du J, Jin Y, Ju D, Huang C, Hong Y, Liu T, Zhao W, Wang J, Zheng B, Wang L, Liu S, Luo X, Luo S, Xu X, Hu J, Pu J, Chen S, Sun Y, Jiang S, Wei L, Fu X, Bai Y, Yang S, Hu W, Zhang G, Pan C, Zhang S, Wang Y, Cao W, Yang S, Zhang J, Guo F, Wen H, Zhang J, Song J, Yue C, Li L, Wu D, Tian Y, Yang J, Lu M, Saver JL, Nogueira RG, Zi W, Yang Q. Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):543-553. doi: 10.1001/jama.2022.12584.

    PMID: 35943471BACKGROUND

  • Zhong HL, Zhou TF, He YK, Li TX, Li ZS. Safety and efficacy of adjunct tirofiban treatment following mechanical thrombectomy for acute ischemic stroke patients with large vessel occlusion (LVO) resulting in successful reperfusion. Interv Neuroradiol. 2024 Oct;30(5):657-662. doi: 10.1177/15910199221138883. Epub 2022 Nov 10.

    PMID: 36358016BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TirofibanLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Xiang Luo

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

April 9, 2024

Primary Completion

December 29, 2025

Study Completion

December 29, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)