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

Not Applicable

Not yet recruiting

• Conditions: Stroke, Ischemic
• Interventions: Drug: Intravenous tirofiban before endovascular thrombectomy; Drug: Intravenous placebo before endovascular thrombectomy

• Registration Number: NCT07135089
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-10-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 884

Inclusion Criteria

• Age ≥ 18;
• Patients presenting with acute ischemic stroke within 12 hours of time last known well
• It is preliminarily diagnosed as anterior circulation ischemic stroke based on clinical symptoms or imaging examinations;
• National Institute of Health Stroke Scale (NIHSS) ≥ 6;
• ASPECTS ≥ 6 on CT;
• occlusion of the intracranial internal carotid artery or the first or second segment of the middle cerebral artery confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography;
• Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria

• History of atrial fibrillation or atrial flutter, or 12-lead ECG 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;
• Dual antiplatelet drugs are taken within one week, direct oral anticoagulants (DOACs), warfarin and other drugs that increase the risk of bleeding, Modified Rankin Scale score before stroke onset >2;
• Participate in other clinical trials or be unable to complete the follow-up;
• Allergy to drugs or contrast agents, pregnancy or lactation, uncontrollable hypertension, bleeding constitution, deficiency of anticoagulant factors or INR > 1.7, abnormal blood sugar, platelet count < 90×10⁹/L;
• Severe renal insufficiency and advanced disease with an expected life expectancy of less than 6 months;
• Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirofiban group	Intravenous tirofiban before endovascular thrombectomy	Intravenous tirofiban before endovascular thrombectomy
Placebo group	Intravenous placebo before endovascular thrombectomy	Intravenous placebo before Endovascular Thrombectomy

Primary Outcome Measures

Name	Time	Method
The level of global disability at 90 days, based on the modified Rankin Scale (mRS)	Day 90

Secondary Outcome Measures

Name	Time	Method
Ordinal distribution of modified Rankin Score (mRS)	Day 90
The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b)	immediately after first catheter angiogram	Substantial reperfusion was defined as an expanded Thrombolysis In Cerebral Infarction grade of 2b50 (substantial reperfusion), 2c (nearcomplete reperfusion), or 3 (complete reperfusion).
The proportions of patients with substantial reperfusion at final angiogram	immediately after final angiogram
The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment	24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS)	24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)	7 (-2/+2) days
The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification within 48 hours	24 (-6/+24) hours
The incidence of non-intracranial hemorrhage complications	24 (-6/+24) hours
Serious adverse events	7 (-2/+2) days	eg, acute respiratory failure, large or malignant middle cerebral artery infarction, acute heart failure, hemicraniectomy
The proportion of patients without disability (mRS score of 0 to 1) or who returned to their premorbid mRS score at 90 days (for patients with prestroke mRS score >1)	Day 90
The proportion of patients with functional independence (mRS score of 0 to 2) at 90 days	Day 90
Procedure-associated complications	Periprocedural
The proportion of patients withthrombocytopenia	24 (-6/+24) hours
The incidence of mortality within 90 days	Day 90

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China