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

Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban (INSIST-IT2): a Prospective, Randomized, Double Blinded, Multi-center Study

This trial will test whether giving IV tirofiban before endovascular clot removal helps people with anterior-circulation large-vessel ischemic stroke due to intracranial atherosclerosis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 870 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07135089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with anterior-circulation large-vessel occlusion suspected to be caused by intracranial atherosclerosis who are eligible for thrombectomy within 12 hours, with NIHSS ≥6, ASPECTS ≥6, and pre-stroke mRS ≤2 are ideal candidates.

Not a fit: Patients with atrial fibrillation/flutter, hemorrhagic stroke, posterior-circulation occlusions, very large infarcts (low ASPECTS), or those outside the 12-hour window are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce post-procedure disability by protecting brain tissue and improving outcomes after thrombectomy.

How similar studies have performed: Smaller observational studies and some nonrandomized reports have suggested potential benefit of glycoprotein IIb/IIIa inhibitors like tirofiban in selected stroke patients, but randomized evidence is limited and the approach remains unproven.

Eligibility criteria

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 this trial is running

Shenyang, Liaoning

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

Study contacts

• Study coordinator: Hui-Sheng Chen

Conditions Stroke, Ischemic