Clinical Trial: Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen(CLEAR-FDR)

Brief 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 Summary:

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 da
Sponsor: Arthur Pancioli

Current Primary Outcome: The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH). [ Time Frame: within 36 hours after stroke onset ]

Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator


Original Primary Outcome: The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH). [ Time Frame: 36 hours after stroke onset ]

Current Secondary Outcome:

  • The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH). [ Time Frame: within 36 hours after stroke onset ]
    Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)
  • The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2). [ Time Frame: within 36 hours after stroke onset ]
    Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT


Original Secondary Outcome:

  • The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH). [ Time Frame: 36 hours after stroke onset ]
  • The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2). [ Time Frame: 36 hours after stroke onset ]


Information By: University of Cincinnati

Dates:
Date Received: October 18, 2013
Date Started: September 2013
Date Completion:
Last Updated: December 16, 2015
Last Verified: October 2015