Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban (INSIST-IT2)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Enrolling; Phase 3

Conditions: Stroke, Ischemic

Treatments: Drug: Intravenous placebo before endovascular thrombectomy; Drug: Intravenous tirofiban before endovascular thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07135089

Y(2025)114

Details and patient eligibility

About

It remains uncertain whether intravenous tirofiban administered before endovascular thrombectomy could improve disability severity for patients with LVO due to intracranial atherosclerosis.The current study aimed to assess the efficacy and safety of administering intravenous tirofiban before endovascular thrombectomy for improving clinical outcomes in patients with anterior circulation LVO due to intracranial atherosclerosis.

Enrollment: 870 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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870 participants in 2 patient groups, including a placebo group

Tirofiban group

Experimental group

Description:

Intravenous tirofiban before endovascular thrombectomy

Treatment:

Drug: Intravenous tirofiban before endovascular thrombectomy

Placebo group

Placebo Comparator group

Description:

Intravenous placebo before Endovascular Thrombectomy

Treatment:

Drug: Intravenous placebo before endovascular thrombectomy