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

Phase 3RecruitingNCT07135089

General Hospital of Shenyang Military Region870 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

870

Conditions

Stroke, Ischemic

Interventions

Intravenous tirofiban before endovascular thrombectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2)

mRS ranges from 0-6, with high score meaning poor outcome

Time frame: Day 90

Secondary Outcomes

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)

mRS ranges from 0-6, with high score meaning poor outcome

Time frame: Day 90

ordinal distribution of modified Rankin Scale (mRS)

mRS ranges from 0-6, with high score meaning poor outcome

Time frame: Day 90

The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b)

Substantial reperfusion was defined as an expanded Thrombolysis In Cerebral Infarction grade of 2b50 (substantial reperfusion), 2c (nearcomplete reperfusion), or 3 (complete reperfusion).

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)

NIHSS ranges from 0-42, with high score meaning poor outcome

Time frame: 24 (-6/+24) hours

change in National Institute of Health stroke scale (NIHSS)

NIHSS ranges from 0-42, with high score meaning poor outcome

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

eg, acute respiratory failure, large or malignant middle cerebral artery infarction, acute heart failure, hemicraniectomy

Time frame: 7 (-2/+2) days

Procedure-associated complications

Time frame: Periprocedural

The proportion of patients with thrombocytopenia

Time frame: 24 (-6/+24) hours

The incidence of mortality

Time frame: Day 90

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts