Intravenous Tirofiban Versus Thrombolysis Before Mechanical Thrombectomy in Stroke
ADJUVANT
Intravenous Adjuvant With Tirofiban Versus Thrombolysis Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.
1 other identifier
interventional
1,014
1 country
42
Brief Summary
In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or thrombolysis before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
42 active sites
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 2, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2026
CompletedSeptember 14, 2026
September 1, 2026
2.5 years
February 2, 2023
September 9, 2026
Conditions
Keywords
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
Secondary Outcomes (10)
Modified Rankin scale score at 90 days
90 days post-endovascular treatment
Excellent outcome
90 days post-endovascular treatment
Successful reperfusion before thrombectomy
Prior to thrombectomy
Successful reperfusion on the final angiogram
End-of-procedure angiography
First pass excellent reperfusion
After the first thrombectomy pass
- +5 more secondary outcomes
Other Outcomes (3)
Symptomatic intracranial hemorrhage within 48 hours
Within 48 hours post-endovascular treatment
Any intracranial hemorrhage within 48 hours
Within 48 hours post-endovascular treatment
Mortality at 90 days
90 days post-endovascular treatment
Study Arms (2)
Tirofiban
EXPERIMENTALTirofiban will be administrated intravenously before endovascular thrombectomy.
Thrombolysis
ACTIVE COMPARATORThrombolytics will be administrated intravenously before endovascular thrombectomy.
Interventions
Intravenous tirofiban before endovascular thrombectomy.
Intravenous thrombolysis before endovascular thrombectomy.
Eligibility Criteria
You may qualify if:
- Aged 18 years or older;
- Acute ischemic stroke patient eligible for intravenous thrombolysis who are present within 4.5 hours of last known well, or present within 4.5-24 hours of last known well with demonstrated salvageable brain tissue (defined as an estimated ischemic core volume \<70 ml, a mismatch ratio ≥1.8 and a mismatch volume ≥15 ml);
- Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, or basilar artery confirmed by CTA or MRA;
- Endovascular thrombectomy is planned by clinical care team;
- Informed written consent obtained from patients or their legal representatives.
You may not qualify if:
- Acute intracranial hemorrhage on admission;
- Contraindication to intravenous thrombolytics or tirofiban;
- Pretreatment with intravenous thrombolysis after index stroke;
- Significant pre-stroke disability defined as a modified Rankin scale (mRS) score greater than 2;
- Known pregnancy or lactation;
- Allergy to radiographic contrast agents, nickel, titanium metals or their alloys;
- Current participation in other drug clinical trials;
- Arterial tortuosity and/or other arterial disease that would prevent the thrombectomy device from reaching the target vessel;
- Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments;
- Radiologically confirmed mass effect or intracranial tumor except for small meningioma;
- Radiologically confirmed intracranial arteriovenous malformation or aneurysm.
- Any terminal disease with a life expectancy less than half a year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Taihe County People's Hospital
Fuyang, Anhui, 236600, China
Yijishan Hospital of Wannan Medical University
Wuhu, Anhui, 241000, China
Longyan First Hospital of Fujian Medical University
Longyan, Fujian, 364000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Quanzhou County People's Hospital
Quanzhou, Guangxi, 541500, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570100, China
The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)
Jiaozuo, Henan, 454000, China
Shenqiu County People's Hospital
Shenqiu, Henan, 466300, China
Xihua People's Hospital
Wacheng Neighborhood, Henan, 466600, China
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan, 421001, China
Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)
Xiangtan, Hunan, 411100, China
Huai'an First People's Hospital, the Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University
Huai'an, Jiangsu, 223300, China
The 904th Hospital of The People's Liberation Army
Wuxi, Jiangsu, 214000, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000, China
Xingguo People's Hospital, Xinguo Hospital of Gannan Medical University
Ganzhou, Jiangxi, 342414, China
Jingdezhen First People's Hospital
Jingdezhen, Jiangxi, 333000, China
Chongzhou People's Hospital
Chongzhou, Sichuan, 611230, China
The First People's Hospital of Mianyang (Mianyang 404 Hospital)
Mianyang, Sichuan, 621000, China
Dali Bai Autonomous Prefecture People's Hospital
Dali, Yunnan, 671000, China
Changxing people's hospital
Changxing, Zhejiang, 313100, China
Haining People's Hospital
Haining, Zhejiang, 314400, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310012, China
HuZhou Central Hospital
Huzhou, Zhejiang, 313000, China
The First People's Hospital of Huzhou
Huzhou, Zhejiang, 313000, China
The First People's Hospital of Jiashan
Jiashan, Zhejiang, 314100, China
The Second Affiliated Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
Linhai Second People's Hospital
Linhai, Zhejiang, 317016, China
Lishui People's Hospital
Lishui, Zhejiang, 323000, China
The Affiliated First Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315040, China
Beilun District People's Hospital
Ningbo, Zhejiang, 315800, China
The First People's Hospital of Pinghu
Pinghu, Zhejiang, 314200, China
Affiliated Shaoxing Shangyu People's Hospital, School of Medicine, Zhejiang University
Shangyu, Zhejiang, 312300, China
Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University
Taizhou, Zhejiang, 317000, China
Taizhou Central Hospital（Taizhou University Affiliated Hospital）
Taizhou, Zhejiang, 318000, China
Taizhou municipal hospital
Taizhou, Zhejiang, 318000, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020, China
The First People's Hospital of Tongxiang
Tongxiang, Zhejiang, 314500, China
The First People's Hospital of Wenling
Wenling, Zhejiang, 317500, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Haiyan People's Hospital
Wuyuan, Zhejiang, 314300, China
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: 33464335RESULTRESCUE 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: 35943471RESULTSang 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 17;15(6):e045967. doi: 10.1161/JAHA.125.045967. Epub 2026 Mar 4.
PMID: 41778584RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Congguo Yin, Doctor
Hangzhou First Hospital of Westlake University
- PRINCIPAL INVESTIGATOR
Zhongming Qiu, Doctor
The 903rd Hospital of PLA, China
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
May 25, 2026
Study Completion
May 25, 2026
Last Updated
September 14, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After the primary results was published