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All of the important stroke studies are considered in this and the subsequent
sections.
Recombinant tissue-type plasminogen activator (rt-PA) improves outcomes for patients with acute ischaemic stroke,
but current approved use is limited to within 3 hours of symptom onset. This restricts the number of patients who
can be treated, since most stroke patients present more than 3 hours after symptom onset. The objective was to test the
efficacy and safety of rt-PA in patients with acute ischaemic stroke when administered between 3 and 5 hours after
symptom onset. The Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischaemic Stroke (ATLANTIS) study
is a phase 3, placebo-controlled, double-blind randomized study conducted between December 1993 and July 1998, with
up to 90 days of follow-up.
rt-PA - The Studies: ATLANTIS
Design
- Started with 3-6 hours, later 3-5 hours, two substudies (A,B)
- Slow recruitment, total number of patients 547
- Symptom- and computed tomography (CT)-based, ECASS criteria
- Dosage 0.9 mg/kg (max. dose 90 mg)
Results
- Neutral result, no benefit in combined analysis
- Increased risk of symptomatic haemorrhages
- No significant difference in mortality
ATLANTIS had a very difficult start. It started with a 3 to 6 hour time window, and later used a 3 to 5 hour time
window. The recruitment was very slow and took several years. The results did not show any benefit for the patients
treated in that trial, a finding that is hardly explained, but that also did not affect the meta-analysis.
PubMed Abstract
Reference:
Clark et al. JAMA 1999; 282 (21): 2019-2026. |
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© 2005 Boehringer Ingelheim GmbH, Germany. All rights reserved.
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