NCT05728333

Brief Summary

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress91%
Nov 2023Jul 2026

First Submitted

Initial submission to the registry

February 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

February 2, 2023

Last Update Submit

December 18, 2025

Conditions

Stroke, Acute Ischemic

Keywords

endovascular thrombectomylarge vessel occlusionintravenous thrombolysistirofiban

Outcome Measures

Primary Outcomes (1)

  • Functional independence

    modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

    90 days post-endovascular treatment

Study Arms (2)

Tirofiban

EXPERIMENTAL

Tirofiban will be administrated intravenously before endovascular thrombectomy.

Drug: Tirofiban

Alteplase

ACTIVE COMPARATOR

Alteplase will be administrated intravenously before endovascular thrombectomy.

Drug: Alteplase

Interventions

TirofibanDRUG

Intravenous tirofiban before endovascular thrombectomy.

Also known as: Tirofiban & EVT
Tirofiban
AlteplaseDRUG

Intravenous alteplase before endovascular thrombectomy.

Also known as: Alteplase & EVT
Alteplase

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or older.
  • Presenting with acute ischemic stroke symptom.
  • Time from onset to hospital arrival:
  • (1) within 4.5 hours
  • Eligible for intravenous thrombolysis.
  • Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.
  • Informed consent obtained from patients or their legal representatives.

You may not qualify if:

  • CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);
  • Contraindications of IV rt-PA or tirofiban;
  • Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
  • Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
  • Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
  • CT or MRI evidence of mass effect or intracranial tumor (except small eningioma);
  • CT or MRI evidence of cerebral vasculitis;
  • CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms;
  • Any terminal illness with life expectancy less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

  • Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.

    PMID: 33464335RESULT

  • 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: 35943471RESULT

  • Sang H, Zheng Z, Ni H, Gu X, Xia W, Huang H, Liu K, Zhou Y, Jiang L, Li L, Yuan G, Cui T, Jiang S, Li Y, Jiang Y, Fang X, Huang X, Li M, Liu F, Lin C, Fan X, Feng D, Zhang L, Campbell BCV, Albers GW, Nogueira RG, Nguyen TN, Wang D, Saver JL, Yang Q, Qiu Z, Yin C; ADJUVANT investigators. ADJUVANT Randomized Controlled Trial: Rationale and Design. J Am Heart Assoc. 2026 Mar 4:e045967. doi: 10.1161/JAHA.125.045967. Online ahead of print.

    PMID: 41778584DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TirofibanTissue Plasminogen Activator

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 ProteinsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsBiological Factors

Study Officials

  • Congguo Yin, Doctor

    Hangzhou First Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

  • Zhongming Qiu, Doctor

    The 903rd Hospital of PLA, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongfei Sang, Doctor

CONTACT

+8613738132047sanghongfei1988@163.com

Zhongming Qiu, Doctor

CONTACT

+8613236599269qiuzhongmingdoctor@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 15, 2023

Study Start

November 28, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the primary results was published

Locations

CN(1)