Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)
Condition: Stroke; Brain Infarction
MeSH terms: Stroke; Ischemic Stroke; Brain Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of this trial is to determine if individuals with acute ischemic stroke
      treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV
      eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome
      than individuals treated with standard IV rt-PA alone.
    

Detailed description: 
      The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Full
      Dose Regimen (CLEAR-FDR Stroke Trial) is a Phase II trial and part of the Specialized Program
      on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to
      enhance delivery of acute stroke patient care and train acute stroke translational
      researchers.

      Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood
      clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get
      enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can
      affect a person's ability to walk, talk, and function independently. In order to reduce the
      risk of permanent damage, it is important to restore blood flow to the brain as quickly as
      possible.

      rt-PA, used alone, is already approved by the Food and Drug Administration (FDA) as treatment
      for patients with a stroke caused by blockage of an artery in the brain and when given within
      3 hours of the onset of stroke symptoms. Eptifibatide is also already FDA-approved as a
      treatment for blood clots causing heart attack. The investigational aspect of this study is
      the use of eptifibatide for a stroke victim in combination with rt-PA.

      The CLEAR Stroke Trial demonstrated that the combination of low dose rt-PA plus eptifibatide
      can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.

      The CLEAR-ER Stroke Trial demonstrated that the combination of medium dose rt-PA plus
      eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom
      onset.

      The CLEAR-FDR Stroke Trial is designed to provide data concerning the risks when combining
      eptifibatide with full dose intravenous rt-PA in 30 acute ischemic stroke patients within 3
      hours of symptom onset.
    

Intervention name(s): Eptifibatide
Intervention type(s): Drug
Intervention description(s): IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Other intervention name(s): Integrilin
Intervention MeSH terms: Eptifibatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute ischemic stroke; stroke; rt-PA, thrombolytic; t-PA; recombinant tissue plasminogen activator; Activase; eptifibatide; Integrilin; fibrinolytic agents; clot dissolving; blood clot