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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
HAEST
Heparin in Acute Embolic Stroke Trial



Principal Investigator
Dr. E. Berge

PI Address
Ullevål University Hospital, Department of Haematology, Haematological Research Laboratory, N-0407 Oslo, Norway

Contact Email
eivind.berge@ulleval.no



Trial Phase:Phase III
Study Size Actual:449
Max Time from onset:30 Hours
Min Age:18
Status:
Trial complete. Results published in April of 2000.

Purpose:
To test whether treatment with low molecular weight heparin (LMWH) is superior to aspirin for the prevention of recurrent stroke during the first 14 days.

Interventions:
Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2
Dalteparin
Low molecular weight heparin
LMW heparin
Low molecular weight heparin and heparinoids. See also specific compounds, including danaparoid, dalteparin, enoxaparin, nadroparin, tinzaparin.

Year Published: 2000


Design:
Multicenter, randomized, double-blind, and dummy-controlled trial of 449 patients.

Inclusion Criteria
Acute ischemic stroke and atrial fibrillation within 30 hours of stroke onset. Aged 18 years or older.

Exclusion Criteria
Clear indication for anticoagulant therapy or a clear contraindication for antithrombotic therapy, Scandinavian Stroke Scale score below 8, serious persistent hypertension on repeated measurements, previous severe mental or physical disability that might interfere with patient assessment, other serious disease, pregnancy or breast feeding.

Patient Involvement:
Patients were randomized to receive dalteparin 100 IU/kg subcutaneously twice a day) and placebo or aspirin (160 mg every day).

Primary Outcome:
Ischemic stroke recurrence during first 14 days of treatment.

Secondary Outcome:
Symptomatic cerebral hemorrhage, symptomatic and asymptomatic cerebral hemorrhage, progression of symptoms within first 48 hours, death and functional outcome.

Results:
The frequency of recurrent ischemic stroke during the first 14 days was 19/244 (8·5%) in dalteparin-allocated patients versus 17/225 (7·5%) in aspirin-allocated patients (odds ratio=1·13, 95% CI 0·57-2·24). The secondary events during the first 14 days also revealed no benefit of dalteparin compared with aspirin: symptomatic cerebral hemorrhage 6/224 versus 4/225; symptomatic and asymptomatic cerebral hemorrhage 26/224 versus 32/225; progression of symptoms within the first 48 hours 24/224 versus 17/225; and death 21/224 versus 16/225. There were no significant differences in functional outcome or death at 14 days or 3 months.

Source of Information:
Lancet 355: 1205 - 1210, 2000.

Web Links and Publications:
Low molecular-weight heparin versus aspirin in patients with acute ischaemic stroke and atrial fibrillation: a double-blind randomised study. HAEST Study Group. Heparin in Acute Embolic Stroke Trial.
Lancet 2000 Apr 8;355(9211):1205-10

This information last updated on: 9/21/2000

UID: 92

   

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