Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
Condition: Ischemic Stroke; Stroke; Brain Infarction
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Brain Infarction; Ischemia; 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 medium dose of IV 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 (recombinant tissue
      plasminogen activator) in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER 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 (NCT00250991) 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 is designed to provide data concerning the risks and benefits of
      combining eptifibatide with medium dose intravenous rt-PA in 126 acute ischemic stroke
      patients within 3 hours of symptom onset. Patients will be randomized to a combined
      intravenous medium-dose rt-PA and eptifibatide regimen, or standard dose rt-PA in a 5 to 1
      ratio. This will result in a total of 105 patients treated with a combined regimen, and 21
      patients treated with standard dose IV rt-PA alone.
    

Intervention name(s): Eptifibatide; rt-PA
Intervention type(s): Drug; 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.; Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.
Other intervention name(s): Integrilin; Activase
Intervention MeSH terms: Eptifibatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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