IV tirofiban given before clot removal for anterior large-vessel ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 3 study compares intravenous tirofiban to placebo administered immediately before endovascular thrombectomy in adults with anterior-circulation large-vessel occlusion suspected to be caused by intracranial atherosclerosis. Eligible patients present within 12 hours of symptom onset, have NIHSS ≥6, ASPECTS ≥6, and a pre-stroke mRS ≤2, and receive the assigned infusion prior to the thrombectomy procedure. Outcomes include clinical disability, reperfusion success, and safety measures such as symptomatic intracranial hemorrhage, with clinical follow-up after the procedure. The trial is conducted at a single participating center in Shenyang, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years;
* Anterior circulation large vessel occlusion (the internal carotid artery or the first or second segment of the middle cerebral artery) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA);
* Eligible for endovascular treatment within 12 hours of symptom onset;
* Based on the patient's medical history, clinical presentation, and imaging findings, large artery atherosclerosis is highly suspected as the underlying etiology;
* Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
* Baseline ASPECTS ≥ 6 on CT;
* A pre-stroke modified Rankin Scale (mRS) score of ≤2;
* Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

* History of atrial fibrillation or atrial flutter, or 12-lead Electrocardiogram before randomization and after admission showing atrial flutter or atrial fibrillation;
* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage, or a history of bleeding within one month;
* Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors;
* The following drugs are taken within one week: dual antiplatelet drugs, direct oral anticoagulants (DOACs), warfarin and other drugs that increase the risk of bleeding;
* Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
* Deficiency of anticoagulant factors or international normalized ratio (INR) \> 1.7, platelet count \< 90×10⁹/L;;
* Severe renal insufficiency and advanced disease with an expected life expectancy of less than 6 months;
* Pregnancy or lactation;
* Allergy to drugs or contrast agents;
* Participating in other clinical trials;
* Other conditions that the researcher deems unsuitable for participation in this study.

Where it's running

• General Hospital of Northern Theater Command
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Hui-Sheng Chen
• Email: chszh@aliyun.com
• Phone: +86-024-28897511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.