Fraxiparin and prevention of left ventricular thrombosis in non-thrombolyzed myocardial infarction. FRATIV Study
Charbonnier, B.
Archives des Maladies du Coeur et des Vaisseaux 90(9): 1215-1221
1997
ISSN/ISBN: 0003-9683 PMID: 9488767 Document Number: 471760
The aim of this trial, undertaken with the participation of 13 centres, was to establish the minimal effective dosage of nadroparin (Fraxiparin) for the prevention of left ventricular mural thrombosis in acute anterior myocardial infarction which was not treated by thrombolysis. Patients had myocardial infarcts less than 3 days old with no previous anticoagulant therapy or for at least 24 hours without mural thrombus in the left ventricle on baseline echocardiography. The protocol consisted of an intravenous bolus of nadroparin of 3.075 IU (0.3 mL) followed by daily subcutaneous injection of either 60 IU/kg/day (group 1) or 100 IU/kg/day (group 2) for 10 days, associated with aspirin. The criterion of judgement was the number of left ventricular thrombi observed in each group: the secondary criteria were the number of deaths, haemorrhagic and thromboembolic events. One hundred and forty-eight patients were included (group 1: 79 patients, group 2: 69 patients). One hundred and nineteen were evaluated for the principal criterion including 12 were considered as failures: 9 deaths (3 in group 1 and 6 in group 2) and 1 recurrent myocardial infarction, 1 ischaemic cerebrovascular attack and 1 atrial fibrillation in group 1. One hundred and seven patients were controlled at Day 0 and Day 10. The incidence of left ventricular mural thrombi was identical in the two groups: 7/56 in group 1 (12.5%) and 9/51 in group 2 (17.6%) (NS). Analysis of secondary criteria showed no difference between the two groups: there were no major haemorrhagic complications. The authors conclude that there is no difference in efficacy between the two dosages of nadroparin. However, the incidence of left ventricular thrombi was globally low in this study (11.6%).