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NCT Number: NCT07135089

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Day 90

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

Secondary outcomes

  1. 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)

    Time frame: Day 90

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

  2. ordinal distribution of modified Rankin Scale (mRS)

    Time frame: Day 90

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

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

    Time frame: 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).

  4. The proportions of patients with substantial reperfusion at final angiogram

    Time frame: immediately after final angiogram

  5. The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment

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

  6. Change in National Institute of Health stroke scale (NIHSS)

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

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

  7. change in National Institute of Health stroke scale (NIHSS)

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

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

  8. The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification

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

  9. The incidence of intraparenchymal hemorrhage (PH1 and PH2)

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

  10. The incidence of non-intracranial hemorrhage complications

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

  11. Serious adverse events

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

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

  12. Procedure-associated complications

    Time frame: Periprocedural

  13. The proportion of patients with thrombocytopenia

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

  14. The incidence of mortality

    Time frame: Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Sheng Chen

CONTACT

[email protected]

+86-024-28897511

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Acronym: INSIST-IT2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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