Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban

Official title

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

Overview

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.

Interventions

• Drug Intravenous tirofiban before endovascular thrombectomy
  The tirofiban was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours.
• Drug Intravenous placebo before endovascular thrombectomy
  The placebo was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours.

Primary outcome measures

• The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2) [Time frame: Day 90]

Secondary outcome measures (12)

• The proportion of patients without disability (modified Rankin Scale [mRS] score of 0 to 1) or who returned to their premorbid mRS score at 90 days (for patients with prestroke mRS score >1) [Time frame: Day 90]
• ordinal distribution of modified Rankin Scale (mRS) [Time frame: Day 90]
• The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b) [Time frame: immediately after first catheter angiogram]
• The proportions of patients with substantial reperfusion at final angiogram [Time frame: immediately after final angiogram]
• The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment [Time frame: 24 (-6/+24) hours]
• Change in National Institute of Health stroke scale (NIHSS) [Time frame: 24 (-6/+24) hours]
• change in National Institute of Health stroke scale (NIHSS) [Time frame: 7 (-2/+2) days]
• The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification [Time frame: 24 (-6/+24) hours]
• The incidence of intraparenchymal hemorrhage (PH1 and PH2) [Time frame: 24 (-6/+24) hours]
• The incidence of non-intracranial hemorrhage complications [Time frame: 24 (-6/+24) hours]
• Serious adverse events [Time frame: 7 (-2/+2) days]
• Procedure-associated complications [Time frame: Periprocedural]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT07135089 · Y(2025)114

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗