antiphospholipid syndrome ( aps ) 1 is a common autoimmune prothrombotic condition characterized by arterial and venous thrombosis and pregnancy morbidity , associated with persistently positive anticardiolipin antibodies ( acl ) and/or lupus anticoagulant ( la ) 2 . concerning therapy , satisfactory results have not yet been obtained in therapy for secondary prevention in ischemic stroke patients with aps . we therefore compared single antiplatelet therapy and a combination of antiplatelet and anticoagulation therapy for secondary prevention in ischemic stroke patients with aps . according to the guidelines of the american heart association ( apass ) 3 for prevention of stroke in patients with ischemic stroke or transient ischemic attack and with antiphospholipid antibodies ( apl ) , antiplatelet therapy is reasonable for cases of cryptogenic ischemic stroke or tia with positive apl . on the other hand , oral anticoagulation with a target inr of 2 to 3 4 is reasonable for patients with ischemic stroke or tia who meet the criteria for aps with venous and arterial occlusive disease in multiple organs , miscarriages , and livedo reticularis . we focused on the secondary prevention of stroke with aps , and compared single antiplatelet therapy and a combination of antiplatelet and anticoagulation therapy in ischemic stroke patients with aps . the subjects were 20 ischemic stroke patients with antiphospholipid antibody ( 10 males and 10 females , mean age 48 years ) , who were hospitalized between october 2002 and november 2004 . they consisted of 13 with primary antiphospholipid syndrome and 7 with sle - related antiphospholipid syndrome . only patients with positive igg beta 2 glycoprotein i ( beta 2-gpi)-dependent anticardiolipin antibody and/or lupus anticoagulant , present on two or more occasions , six weeks or more apart , were selected . eligible patients were randomly assigned to either single antiplatelet therapy ( aspirin 100 mg ) 6 or a combination of antiplatelet and anticoagulation therapy ( target inr : 2.0 - 3.0 ; mean 2.4 0.3 ) for the secondary prevention of stroke , according to a double - blind protocol 3 , 7 . the purpose of the present study was to examine the effects of these regimens on recurrence of stroke . this study was approved by the ethics committee of tokai university , and prior informed consent was obtained from all patients who were eligible to participate . table 1 shows the background of the two groups . there was no significant difference between the two groups in age , gender , nih stroke scale on admission , modified rankin scale ( mrs ) at discharge , or rates of hypertension , diabetes mellitus , hyperlipidemia , and cardiac disease . the echocardiograms detected three mitral valve abnormalities , but these were not thought to be potential embolic sources . two of these patients were randomized to the combination therapy group , and the other to the single modality group . the cumulative incidence of stroke in patients with single antiplatelet treatment was higher than that in patients receiving the combination of antiplatelet and anticoagulation therapy ( log - rank test , p - value = 0.026 ) . however , the patient who had recurrent thrombotic infarction in the combination of antiplatelet and anticoagulation therapy group showed an inr before the recurrence of 2.0 , so the possibility of inadequate treatment can not be ruled out . one minor cerebral hemorrhage was noted in the single antiplatelet therapy group , and one subcutaneous hemorrhage was found in the combination therapy group . as for the patient in the single antiplatelet therapy group who developed cerebral hemorrhage , magnetic resonance angiography of the incidence of hemorrhagic complications was similar in the two groups ( table 2 ) . there is still debate as to which therapy is the most effective for secondary prevention of stroke with aps 4 , 8 , 9 , 10 and concerning the relationship between aps and stroke . it is generally accepted that apl is an independent risk factor for initial ischemic stroke in young adults 11 , 12 . treatment to prevent recurrent stroke and other thrombotic events in aps patients has been reviewed 13 . two groups have retrospective data to suggest that high - intensity warfarin treatment is associated with a better outcome in selected cohorts with various types of thrombotic events 6 . khamashta 14 reported that high - intensity warfarin ( inr over 3.0 ) with or without low - dose aspirin ( 75 mg / day ) was significantly more effective than low - intensity warfarin ( inr under 3.0 ) with or without low - dose aspirin , or treatment with aspirin alone , in preventing further thrombotic events . crowther 7 recently reported the results of the first randomized , double - blind , controlled trial of two different intensities of warfarin treatment on the prevention of recurrent thrombotic events in patients with aps . the high - intensity warfarin treatment was no more effective than moderate - intensity treatment in preventing recurrent thrombotic events . the apass study 3 was the first prospective study of the role of apl in recurrent ischemic stroke , in collaboration with the waps group 8 . this study did not show any difference in effectiveness for secondary prevention between single antiplatelet ( aspirin ) and single anticoagulant ( warfarin ) therapy . derksen 15 examined the effect of low - dose aspirin after first ischemic stroke associated with apl . during about 9 years of follow - up but , we think single antiplatelet therapy may be less effective for the secondary prevention of stroke than the combination of antiplatelet and anticoagulant therapy . although protein c is activated on endothelial cells 16 , we found that serum obtained from patients with positive igg cardiolipin antibodies interfered with protein c activation 2 . is closely associated with factor viii and factor v , this result suggests that the coagulation system is impaired in patients with aps , and so anticoagulant could be effective . aspirin influences endothelial function , and although the effect may be dose - dependent , the dose of 100 mg may be sufficient to improve endothelial function first , diagnosis of aps in waps 8 was not based on the 2006 sydney criteria 5 . as only a single measurement of anticardiolipin antibody and la was obtained , cases with igg beta-2 gpi non - dependent cardiolipin antibody were included . second , the average age of patients ( 63 years ) was significantly older than that in typical aps studies ( 34 years ) . third , the target inr in waps 8 was for cardiogenic stroke caused by non - valvular af . treatment recommendations in this study were based on secondary prevention of ischemic stroke in patients without associated apl . the patients in our study were selected according to the sydney criteria 5 of aps and the average age was consistent with that in typical aps patients . there have not been any previous studies dealing with the combination of antiplatelet and anticoagulant therapy for ischemic stroke patients with aps based on the strict sydney criteria 5 . one reason may be that patients with stroke complicated with aps are rather rare compared with patients with uncomplicated stroke , and this is also the reason why the number of patients in this study was quite small . nevertheless our results seem promising , and a larger study with more patients would be warranted . our results indicate that a combination of antiplatelet and anticoagulation therapy may be more effective than single antiplatelet therapy for secondary prevention in ischemic stroke patients with aps .
satisfactory results have not yet been obtained in therapy for secondary prevention in ischemic stroke patients with antiphospholipid syndrome ( aps ) . 
 we therefore compared single antiplatelet therapy and a combination of antiplatelet and anticoagulation therapy for secondary prevention in ischemic stroke patients with aps.the subjects were 20 ischemic stroke patients with antiphospholipid antibody , 13 with primary antiphospholipid syndrome and 7 with sle - related antiphospholipid syndrome . 
 diagnosis of aps was based on the 2006 sydney criteria . 
 eligible patients were randomly assigned to either single antiplatelet therapy ( aspirin 100 mg ) or a combination of antiplatelet and anticoagulation therapy ( target inr : 2.0 - 3.0 ; mean 2.40.3 ) for the secondary prevention of stroke according to a double - blind protocol . 
 there was no significant difference between the two groups in age , gender , nih stroke scale on admission , mrs at discharge , or rate of hypertension , diabetes mellitus , hyperlipidemia , or cardiac disease . 
 we obtained kaplan - meier survival curves for each treatment . 
 the primary outcome was the occurrence of stroke . 
 the mean follow - up time was 3.92.0 years . 
 the cumulative incidence of stroke in patients with single antiplatelet treatment was statistically significantly higher than that in patients receiving the combination of antiplatelet and anticoagulation therapy ( log - rank test , p - value=0.026 ) . 
 the incidence of hemorrhagic complications was similar in the two groups . 
 the recent apass study did not show any difference in effectiveness for secondary prevention between single antiplatelet ( aspirin ) and single anticoagulant ( warfarin ) therapy . 
 our results indicate that combination therapy may be more effective in aps - related ischemic stroke .