NINDS rt-PA Stroke Trial

About the Trial

The NINDS trial randomized 624 acute ischemic stroke patients to intravenous tPA or placebo within 3 hours of onset. At 3 months, tPA patients were at least 30 percent more likely to have minimal or no disability, despite symptomatic intracranial hemorrhage in about 6 percent. The 1996 FDA approval created emergency stroke treatment where none existed: time is brain became the mantra. ECASS III later extended the window to 4.5 hours. Stroke systems worldwide reorganized around door to needle targets, stroke units, and later thrombectomy. The trial proved acute neurologic rescue is possible and founded modern time critical stroke medicine.