RecruitingPhase 2Phase 3NCT05728333

Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.


Sponsor

Xinqiao Hospital of Chongqing

Enrollment

800 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Aged 18 years or older.
  • Presenting with acute ischemic stroke symptom.
  • Time from onset to hospital arrival:
  • (1) within 4.5 hours
  • Eligible for intravenous thrombolysis.
  • Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.
  • Informed consent obtained from patients or their legal representatives.

Exclusion Criteria9

  • CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);
  • Contraindications of IV rt-PA or tirofiban;
  • Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
  • Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
  • Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
  • CT or MRI evidence of mass effect or intracranial tumor (except small eningioma);
  • CT or MRI evidence of cerebral vasculitis;
  • CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms;
  • Any terminal illness with life expectancy less than 6 months.

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Interventions

DRUGTirofiban

Intravenous tirofiban before endovascular thrombectomy.

DRUGAlteplase

Intravenous alteplase before endovascular thrombectomy.


Locations(1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

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