A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE THE SAFETY AND EFFICACY OF ONCE-DAILY ORG-10172 AND TWICE-DAILY LOW-DOSE HEPARIN IN PREVENTING DEEP-VEIN THROMBOSIS IN PATIENTS WITH ACUTE ISCHEMIC STROKE

A multicentre, double-blind, randomized study was performed in 179 pat ients with acute ischaemic stroke resulting in limb paresis. The purpo se was to compare the safety and efficacy of Org 10172 (1250 anti-Xa U nits s.c. once daily) and heparin sodium (5000 IU s.c. twice daily) in preventing deep-vein thrombosis (DVT). Prophylaxis started within 72 hours of the onset of stroke and continued for at least 9 days. To det ect DVT, patients underwent a daily I-125-fibrinogen leg scanning whic h, if found positive, was followed by venography. A first computed tom ography scan of the brain was performed at screening to rule out cereb ral haemorrhage and a second at cessation of treatment to detect any h aemorrhagic transformations. At the 2-3-months' follow-up period the p atients were examined for signs and symptoms of DVT or pulmonary embol ism. On an intention-to-treat analysis, DVT occurred in 14.6% of patie nts receiving Org 10172 and in 19.8% of those receiving heparin during the treatment period (p = 0.392, NS). Pulmonary embolism was diagnose d in one patient in each group. Major conversion to a symptomatic haem orrhagic brain infarct was found in one patient in each group. Death o ccurred in 13.5% of patients treated with Org 10172 and in 6.7% of pat ients treated with heparin (p = 0.135, NS). Deaths were mainly related to pulmonary infection and cerebral oedema, thus considered to be due directly to the clinical status of the patients. 1250 anti-Xa Units o f Org 10172 once daily is both safe and as effective as 5000 IU of hep arin sodium twice daily given for DVT prophylaxis in patients with acu te ischaemic stroke of recent onset.