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NCT07135089RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 9 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
870 (estimated)
First submitted
12 Aug 2025
Start date
13 Nov 2025
Primary completion date
30 Sept 2027
Lead sponsor
General Hospital of Shenyang Military Region
Diseases
Stroke
NCT number
NCT07135089

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 870
  • From 13 Nov 2025 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • 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);
  • Severe renal insufficiency and advanced disease with an expected life expectancy of less than 6 months;
  • Allergy to drugs or contrast agents;
  • Other conditions that the researcher deems unsuitable for participation in this study.

Lab values

  • Deficiency of anticoagulant factors or international normalized ratio (INR) \> 1.7, platelet count \< 90×10⁹/L;;

Other

  • Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors;
  • Pregnancy or lactation;
  • Participating in other clinical trials;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
General Hospital of Northern Theater Command
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.