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

NCT07135089 | Recruiting Phase 3 DMC

• 1 other identifier: Y(2025)114
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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

  Day 90

Secondary Outcomes (14)

• 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)

  Day 90

• ordinal distribution of modified Rankin Scale (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

• 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

Study Arms (2)

Tirofiban group

EXPERIMENTAL

Intravenous tirofiban before endovascular thrombectomy

Drug: Intravenous tirofiban before endovascular thrombectomy

Placebo group

PLACEBO COMPARATOR

Intravenous placebo before Endovascular Thrombectomy

Drug: Intravenous placebo before endovascular thrombectomy

Interventions

Intravenous tirofiban before endovascular thrombectomy DRUG

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.

Tirofiban group

Intravenous placebo before endovascular thrombectomy DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hui-Sheng Chen

CONTACT

+86-024-28897511; chszh@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 21, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CN (1)