ATLANTIS
Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke
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Status:
Trial was halted in July of 1998 due to lack of efficacy at interim analysis. Results published in December of 1999.
Purpose:
To assess the efficacy and safety of 0.9 mg/kg intravenous rtPA (Alteplase) vs placebo in acute ischemic stroke patients treated within 3 to 5 hours of stroke onset.
Location(s):
North America
Year Finished:
1998
Year Presented:
1999
Design:
Placebo-controlled, double-blind, randomized study of 613 patients at 140 centers.
Inclusion Criteria
Ischemic stroke causing measurable neurological deficit presenting within 5 hours of onset, aged 18-79.
Exclusion Criteria
ICH as determined by CT scan, signs of cerebral ischemia in more than one third of the territory of the middle cerebral artery, only minor stroke symptoms or major symptoms that are rapidly improving, history of stroke within previous 6 months, coma, severe obtundation, fixed eye deviation, or complete hemiplegia, previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation, or aneurysm, clinical presentation suggestive of subarachnoid hemorrhage, hypertension, presumed septic embolus, presumed pericarditis or presence of ventricular thrombus or aneurysm related to recent acute myocardial infarction, recent surgery or biopsy of a parenchymal organ, recent trauma with internal injuries or ulcerative wounds, recent head trauma, active or recent hemorrhage, known hereditary or acquired hemorrhagic diathesis, unsupported coagulation factor deficiency or oral anticoagulant therapy with prothrombin time greater than normal, pregnancy, lactation or parturition within previous 30 days, abnormal blood lab values, serious, advanced or terminal illness, current participation in another investigational drug trial.
Patient Involvement:
272 patients received Alteplase and 275 received placebo.
Primary Outcome:
NIH Stroke Scale (NIHSS) score <= 1.
Secondary Outcome:
Barthel Index, modified Rankin scale, and Glasgow Outcome Scale at 30 days and 90. Serious adverse events were also assessed.
Results:
In the target population, 32% of placebo patients and 34% of rt-PA patients had NIHSS score <=1 at 90 days (p=0.65). There were no differences in any of the secondary functional outcome measures. Adverse events included significant increases in the rate of symptomatic intracerebral hemorrhage (ICH) (1.1% vs. 7.0%, p<0.001), asymptomatic ICH (4.7% vs. 11.4%, p=0.004), and fatal ICH (0.3% vs. 3.0%, p<0.001). Mortality at 90 days was 6.9% in placebo patients and 11.0% with rt-PA (p=0.09).
Source of Information:
JAMA 1999 Dec 1;282(21):2019-26.
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This information last updated on: 9/21/2000
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