NCT00250991

Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.

Detailed description

The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) trial is 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. The CLEAR Stroke study will enroll 100 participants with acute stroke due to a blood clot. The purpose of this multi-center, randomized, double-blind study is to determine the effects of using a combination of two drugs, integrilin (or eptifibatide) and activase (or recombinant tissue plasminogen activator, rt-PA, recombinant t-PA), to dissolve blood clots. More specifically, the CLEAR study is being done to determine if a lower dose of activase, given in combination with a second drug, integrilin, is a safe treatment for acute stroke. Activase, 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. Integrilin is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of integrilin for a stroke victim in combination with activase.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	activase
DRUG	integrilin

Timeline

• Start date: 2003-07-01
• Completion: 2007-07-01
• First posted: 2005-11-09
• Last updated: 2009-05-08

Locations

19 sites across 1 country: United States