Tirofiban for Patients Treated With Alteplase

Overview

After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.

Full Title of Study: “A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2020

Interventions

  • Drug: Tirofiban
    • Tirofiban Injection after the alteplase intravenous thrombolysis
  • Drug: Alteplase
    • Only alteplase intravenous thrombolysis

Arms, Groups and Cohorts

  • Experimental: Tirofiban and alteplase
  • Placebo Comparator: Alteplase

Clinical Trial Outcome Measures

Primary Measures

  • The rate of favorable outcome
    • Time Frame: 90 days
    • favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale

Secondary Measures

  • mRS ≤2
    • Time Frame: 90 days
  • NIHSS score
    • Time Frame: 7 days
  • Deterioration after improvement
    • Time Frame: 24 hours
  • Final infarct size
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 – Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines. – 6≤ NIHSS ≤20 before IV tPA, or NIHSS >20 but decrease ≥ 8 after IV rt-PA. – ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage – Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form Exclusion Criteria:

  • Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines. – Patients had used antiplatelet therapy in the past 5 days before the stroke. – Patients had used anticoagulant therapy in the past 5 days before the stroke. – Scheduled for surgery or interventional treatment requiring study drug cessation. – CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory. – Any evidence of clinically significant bleeding ,or known coagulopathy. – Renal insufficiency (creatinine clearance rate <30ml/min) – Hepatic dysfunction (ALT >2 folds of Upper limit of normal value or AST>2 folds of Upper limit of normal value). – Pre-existing disability with ≥ mRS 2. – Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist. – Severe non-cerebrovascular disease with life expectancy <3 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Capital Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji Xunming,MD,PhD, Principal Investigator – Capital Medical University

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