NINDS played a major role in the development of tPA, from funding early studies that provided a rationale for its use, to leading pivotal clinical trials that supported the treatment’s FDA approval in 1996. Print Overview and Timeline (pdf, 424 KB) These efforts revolutionized stroke care, and the success of tPA set the stage for additional approved treatments after decades of little hope for effective interventions. Most notably, NINDS scientists recognized the importance of urgent treatment for acute stroke and pioneered efforts to develop protocols for assessing and treating patients with unprecedented speed. When administered quickly after stroke onset (within three hours, as approved by the FDA), tPA helps to restore blood flow to brain regions affected by a stroke, thereby limiting the risk of damage and functional impairment. Known by the generic name alteplase and marketed as Activase® (Genentech), tPA is given to patients through an IV in the arm, and it works by dissolving blood clots that block blood flow to the brain. Another major advance was the clot-dissolving medicine tPA (for tissue plasminogen activator), the first treatment for acute ischemic stroke to receive Food and Drug Administration (FDA) approval. Accordingly, the death rate from stroke in the U.S. Stroke is a leading cause of death and disability both globally and in the U.S., where approximately 800,000 people experience a stroke each year 1.Īlthough stroke remains a critical health issue, better management of cardiovascular risk factors, greater awareness of symptoms, and prompt medical attention are helping to prevent strokes and improve outcomes. A stroke occurs when the blood supply to brain tissue is blocked by a blood clot (ischemic stroke), or when a blood vessel in the brain ruptures (hemorrhagic stroke), causing brain cells to die and leading to functional impairments.
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