Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) (CLEAR-FDR)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 The Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Full Dose Regimen(CLEAR-FDR)|
- The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH). [ Time Frame: within 36 hours after stroke onset ] [ Designated as safety issue: Yes ]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
- The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH). [ Time Frame: within 36 hours after stroke onset ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT
- The Number of Participants With Good Outcomes According to the Modified Rankin Score. [ Time Frame: 90 days from the date of stroke onset ] [ Designated as safety issue: No ]Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.
|Study Start Date:||September 2013|
|Study Completion Date:||April 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
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 Name: Integrilin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01977456
|United States, Kentucky|
|St. Elizabeth Healthcare System Edgewood|
|Edgewood, Kentucky, United States, 41017|
|St. Elizabeth Healthcare Florence|
|Florence, Kentucky, United States, 41042|
|St. Elizabeth Healthcare Ft. Thomas|
|Ft. Thomas, Kentucky, United States, 41075|
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45219|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|Cincinnati, Ohio, United States, 45236|
|Bethesda North Hospital|
|Cincinnati, Ohio, United States, 45242|
|Principal Investigator:||Opeolu Adeoye, MD||University of Cincinnati|