MedDataX Logo

Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

NCT ID: NCT05728333

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intravenous alteplase bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Ischemic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endovascular thrombectomy large vessel occlusion intravenous thrombolysis tirofiban

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tirofiban

Tirofiban will be administrated intravenously before endovascular thrombectomy.

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

Intravenous tirofiban before endovascular thrombectomy.

Alteplase

Alteplase will be administrated intravenously before endovascular thrombectomy.

Group Type ACTIVE_COMPARATOR

Alteplase

Intervention Type DRUG

Intravenous alteplase before endovascular thrombectomy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tirofiban

Intravenous tirofiban before endovascular thrombectomy.

Intervention Type DRUG

Alteplase

Intravenous alteplase before endovascular thrombectomy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tirofiban & EVT Alteplase & EVT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18 years or older.
2. Presenting with acute ischemic stroke symptom.
3. Time from onset to hospital arrival:

* (1) within 4.5 hours
4. Eligible for intravenous thrombolysis.
5. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.
6. Informed consent obtained from patients or their legal representatives.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhejiang University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhongming Qiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Congguo Yin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hangzhou First Hospital of Zhejiang University

Zhongming Qiu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The 903rd Hospital of PLA, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hongfei Sang, Doctor

Role: CONTACT

Phone: +8613738132047

Email: [email protected]

Zhongming Qiu, Doctor

Role: CONTACT

Phone: +8613236599269

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hongfei Sang

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 33464335 (View on PubMed)

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.

Reference Type RESULT
PMID: 35943471 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ADJUVANT

Identifier Type: -

Identifier Source: org_study_id