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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

870 Participants
are divided into 2 treatment groups
Group A: Tirofiban groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
Day 90

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)

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

Time frame
Day 90
2

ordinal distribution of modified Rankin Scale (mRS)

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

Time frame
Day 90
3

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

Substantial reperfusion was defined as an expanded Thrombolysis In Cerebral Infarction grade of 2b50 (substantial reperfusion), 2c (nearcomplete reperfusion), or 3 (complete reperfusion).

Time frame
immediately after first catheter angiogram
4

The proportions of patients with substantial reperfusion at final angiogram

Time frame
immediately after final angiogram

Other outcomes

Sponsors and contacts

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