drugset / Trial / NCT00061373

Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST)

NCT00061373

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells. The clot, or thrombus, is made up of platelets and fibrin. The medicine alteplase, also known as tPA , is the standard drug used to treat patients with acute ischemic stroke. tPA attacks the fibrin portion of the blood clot. While intravenous (iv) tPA alone is effective in treating the fibrin part of the clot approximately 30% of the time, adding other commercially available drugs such eptifibatide to treat other clot components may improve the effectiveness of iv tPA therapy. This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin, the low molecular weight heparin tinzaparin, and standard iv tPA therapy for the treatment of acute ischemic stroke. Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage. Also,selection and evaluation of patients by magnetic resonance imaging (MRI) criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose.

Timeline

Start
2003-05
Primary completion
2009-12
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Eptifibatide Other / unclassified 0 ug/kg Intravenous
Subject Eptifibatide Other / unclassified 0.25 ug/kg Intravenous
Subject Eptifibatide Other / unclassified 0.5 ug/kg Intravenous
Subject Eptifibatide Other / unclassified 45 ug/kg Intravenous
Subject Eptifibatide Other / unclassified 90 ug/kg Intravenous
Background Aspirin Small molecule 81 mg Oral
Background Tinzaparin Other / unclassified 80 iu/kg Subcutaneous

Indications