Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. The Lancet. 2007 Jan 27;369(9558):275-282.
Alteplase (Activase), a clot-busting drug routinely given to heart attack patients, is safe and effective for treating stroke and can reduce disability if it is given to patients quickly, scientists said. The adverse event of most concern -symptomatic intracranial hemorrhage-occurred at a similar rate in the postmarketing study as it did in the pooled randomized trials (7.3% versus 8.6%).
Alteplase, a recombinant tissue plasminogen activator also known as tPA, was Food and Drug Administration (FDA)-approved in 1996 as medical therapy for acute ischemic stroke, but European regulators did not follow suit until 2002. Alteplase remains the only FDA-approved thrombolytic for acute stroke although other clot-busters are approved for use in myocardial infarction
The results should confirm tPAs' place in clinical practice in Europe as well as the United States, according to an editorial about the study.
The editorial stated that alteplase is severely underused and few eligible patients are offered the drug, mostly because of apprehension about symptomatic intracranial hemorrhage.