Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban
NCT ID: NCT07135089
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
870 participants
INTERVENTIONAL
2025-11-13
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tirofiban group
Intravenous tirofiban before endovascular thrombectomy
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.
Placebo group
Intravenous placebo before Endovascular Thrombectomy
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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General Hospital of Shenyang Military Region
OTHER
Responsible Party
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Hui-Sheng Chen
Director
Locations
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General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Y(2025)114
Identifier Type: -
Identifier Source: org_study_id
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