Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-ER)
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.
Acute Ischemic Stroke
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The "Combined Approach to Lysis Utilizing Eptifibatide and Rt-PA in Acute Ischemic Stroke-Enhanced Regimen" (CLEAR-ER Stroke Trial)|
- The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage [ Time Frame: 36 hours from symptom onset ] [ Designated as safety issue: Yes ]
- The primary efficacy outcome measure is the modified Rankin Scale score <1 or return to mRS baseline [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Subject will receive the standard dose of IV rt-PA given over an hour. One out of 6 subjects will be in this group.
Intravenous recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy.
Other Name: Activase
Subject will receive the standard dose of IV rt-PA for 40 minutes. This IV dose will be discontinued at 40 minutes. The subject will immediately receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Five out of six subjects will be in this group.
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-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 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.
|United States, California|
|UCLA Ronald Reagan Medical Center|
|Los Angeles, California, United States, 90024|
|University of California San Diego|
|San Diego, California, United States, 92103|
|UCLA Medical Center Santa Monica|
|Santa Monica, California, United States, 90404|
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Kentucky|
|St. Elizabeth Healthcare 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, Maryland|
|Bethesda, Maryland, United States, 20814|
|United States, Michigan|
|University of Michigan Medical Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08903|
|United States, North Carolina|
|Mission Hospital, Inc.|
|Asheville, North Carolina, United States, 28801|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220-2489|
|Mercy Hospital Mt Airy|
|Cincinnati, Ohio, United States, 45239|
|Mercy Hospital, Western Hills|
|Cincinnati, Ohio, United States, 45238|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|The Jewish Hospital|
|Cincinnati, Ohio, United States, 45236|
|Bethesda North Hospital|
|Cincinnati, Ohio, United States, 45242|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, West Virginia|
|West Virginia University Hospital|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Arthur M Pancioli, MD||University of Cincinnati College of Medicine Department of Emergency Medicine|
|Principal Investigator:||Opeolu M Adeoye, MD||University of Cincinnati College of Medicine Department of Emergency Medicine|