Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST)
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
Publications
- Background National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
- Background Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton SA. Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (STARS) study. JAMA. 2000 Mar 1;283(9):1145-50. doi: 10.1001/jama.283.9.1145.
- Background Califf RM. Combination therapy for acute myocardial infarction: fibrinolytic therapy and glycoprotein IIb/IIIa inhibition. Am Heart J. 2000 Feb;139(2 Pt 2):S33-7. doi: 10.1067/mhj.2000.104090.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |