***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Summary Background Rivaroxaban is established for the treatment and secondary prevention of venous thromboembolism , but whether it is useful in patients with antiphospholipid syndrome is uncertain . Methods This r and omised , controlled , open-label , phase 2/3 , non-inferiority trial , done in two UK hospitals , included patients with antiphospholipid syndrome who were taking warfarin for previous venous thromboembolism , with a target international normalised ratio of 2·5 . Patients were r and omly assigned 1:1 to continue with warfarin or receive 20 mg oral rivaroxaban daily . R and omisation was done central ly , stratified by centre and patient type ( with vs without systemic lupus erythematosus ) . The primary outcome was percentage change in endogenous thrombin potential ( ETP ) from r and omisation to day 42 , with non-inferiority set at less than 20 % difference from warfarin in mean percentage change . Analysis was by modified intention to treat . Other thrombin generation parameters , thrombosis , and bleeding were also assessed . Treatment effect was measured as the ratio of rivaroxaban to warfarin for thrombin generation . This trial is registered with the IS RCT N registry , number IS RCT N68222801 . Findings Of 116 patients r and omised between June 5 , 2013 , and Nov 11 , 2014 , 54 who  received rivaroxaban  and 56 who received warfarin were assessed . At day 42 , ETP was higher in the rivaroxaban than in the warfarin group ( geometric mean 1086 nmol/L per min , 95 % CI 957–1233 vs 548 , 484–621 , treatment effect 2·0 , 95 % CI 1·7–2·4 , p<0·0001 ) . Peak thrombin generation was lower in the rivaroxaban group ( 56 nmol/L , 95 % CI 47–66 vs 86 nmol/L , 72–102 , treatment effect 0·6 , 95 % CI 0·5–0·8 , p=0·0006 ) . No thrombosis or major bleeding were seen . Serious adverse events occurred in four patients in each group . Interpretation ETP for rivaroxaban did not reach the non-inferiority threshold , but as there was no increase in thrombotic risk compared with st and ard-intensity warfarin , this drug could be an effective and safe alternative in patients with antiphospholipid syndrome and previous venous thromboembolism . Funding Arthritis Research UK , Comprehensive Clinical Trials Unit at UCL , LUPUS UK , Bayer , National Institute for Health Research Biomedical Research Centre Background : Antiphospholipid syndrome ( APS ) is an acquired thrombophilia characterized by thrombosis , pregnancy morbidity , and the presence of characteristic antibodies . Current therapy for patients having APS with a history of thrombosis necessitates anticoagulation with the vitamin K antagonist warfarin , a challenging drug to manage . Apixaban , approved for the treatment and prevention of venous thrombosis with a low rate of bleeding observed , has never been studied among patients with APS . Aims and Methods : We report study rationale and design of Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome ( ASTRO-APS ) , a prospect i ve r and omized open-label blinded event pilot study that will r and omize patients with a clinical diagnosis of APS receiving therapeutic anticoagulation to either adjusted-dose warfarin or apixaban  2.5 mg twice a day . We aim to report our ability to identify , recruit , r and omize , and retain patients with APS r and omized to apixaban compared with warfarin . We will report clinical ly important outcomes of thrombosis and bleeding . All clinical outcomes will be adjudicated by a panel blinded to the treatment arm . A unique aspect of this study is the enrollment of patients with an established clinical diagnosis of APS . Also unique is our use of electronic medical record interrogation techniques to identify patients who would likely meet our inclusion criteria and use of an electronic portal for follow-up visit data capture . Conclusion : ASTRO-APS will be the largest prospect i ve study to date comparing a direct oral anticoagulant with warfarin among patients with APS for the secondary prevention of thrombosis . Our inclusion criteria assure that outcomes obtained will be clinical ly applicable to the routine management of patients with APS receiving indefinite anticoagulation OBJECTIVES To investigate association between quality of life ( QoL ) and International Normalized Ratio ( INR ) control , with the secondary aim of assessing QoL using generic and anticoagulation-specific , the Short Form Health Survey ( SF-12 ) and the Duke Anticoagulation Satisfaction Scale ( DASS ) . STUDY DESIGN This study assessed anticoagulation related QoL at three time intervals in two groups of patients on long-term warfarin therapy .  METHODS Data of 326 r and omly sample d patients ( 163 patients each in DASS and SF-12 groups ) who had been on warfarin therapy for at least one year at anticoagulation clinics were analysed . QoL was assessed at three time intervals : at the start , six months and one year of warfarin therapy . Indications and target INR ranges and subjects INR values were recorded . Time in Therapeutic Range ( TTR ) was estimated for four subject subgroups , based on target ranges of INR for clustered indications . RESULTS Of the total , 43 % of the subjects were aged between 50 and 64 years , and 51 % were female . DASS assessed subjects older than 35 years perceived significant decrease in overall mean scores of anticoagulation related QoL , whilst all SF-12 assessed subjects perceived an increase in QoL. The mean percentage days in range for all INR target range subgroups did not exceed more than 60 % but there was only a weak correlation ( Rs = 0.104 , P > 0.05 ) between INR control and overall QoL. CONCLUSION Malaysian urban out patients on warfarin treatment longer than one year report a significant overall decrease in QoL , as measured using a vali date d condition-specific instrument . These patients appeared to adapt well to lifestyle limitations imposed by long-term anticoagulation OBJECTIVES The objectives of this study are to examine the efficacy and safety of low-dose aspirin ( LDA ) vs LDA plus low-intensity warfarin ( LDA + W ) in the primary thrombosis prevention of aPL-positive patients with SLE and /or obstetric morbidity and the role of clinical and serological markers in the development of thrombosis . METHODS In this 5-year prospect i ve , r and omized , open , controlled trial , 166 patients with aPL were r and omly assigned using a minimization protocol to receive treatment with LDA ( n = 82 ) or LDA + W [ international normalized ratio ( INR ) = 1.5 ] ( n = 84 ) . Sixty-six patients who declined r and omization were followed up in an observational arm . Clinical and laboratory characteristics and medication side effects were recorded . RESULTS There were no differences in the number of thromboses between patients treated with LDA ( 4/82 ) or LDA + W ( 4/84 ) [ hazard ratio ( HR ) 1.07 , 95 % CI 0.27 , 4.3 ] . The incidence of thrombosis in the r and omized patients was 8/166 ( 1.8 events/100 person-years ) ( HR 1.07 , 95 % CI 0.27 , 4.3 ) and in the observational arm was 7/66 ( 4.9 events/100 person-years ) ( HR 2.43 , 95 % CI 0.87 , 6.79 ) . Sixty-five of 66 patients included in the observational arm received LDA . None of the examined clinical or serological factors appeared to predict thrombosis . Medication side effects included mild gastrointestinal symptoms in the LDA group ( n = 2 ) and bleeding in the LDA + W group ( n = 11 ; 1 nasal and 10 menorrhagia ) . The risk difference for bleeding was 13 % ( CI 6 , 20 ) . CONCLUSION No differences in the number of thromboses were observed between patients treated with LDA vs those treated with LDA + W. More episodes of bleeding were detected in the LDA + W group . The LDA + W regime was significantly less safe and not as acceptable as LDA alone . TRIAL REGISTRATION IS RCT N81818945 ; http://is rct The antiphospholipid syndrome ( APS ) is a systemic autoimmune disease characterized by arterial and venous thrombosis , gestational morbidity and presence of elevated and persistently positive serum titers of antiphospholipid antibodies . The treatment of APS is still controversial , because any therapeutic decision potentially faces the risk of an insufficient or excessive antithrombotic coverage associated with anticoagulation and its major adverse effects . This guideline was elaborated from nine relevant clinical questions related to the treatment of APS by the Committee of Vasculopathies of the Brazilian Society of Rheumatology . Thus , this study aim ed at establishing a guideline that included the most relevant and controversial questions in APS treatment , based on the best scientific evidence available . The questions were structured by use of the PICO ( patient , intervention or indicator , comparison and outcome ) process , enabling the generation of search strategies for evidence in the major primary scientific data bases ( MEDLINE / PubMed , Embase , Lilacs , Scielo , Cochrane Library , Pre medline via OVID ) . A manual search for evidence and theses was also conducted ( BDTD and IBICT ) . The evidence retrieved was selected based on critical assessment by using discriminatory instruments ( scores ) according to the category of the therapeutic question ( JADAD scale for r and omized clinical trials and Newcastle-Ottawa scale for non-r and omized studies ) . After defining the potential studies to support the recommendations , they were selected according to level of evidence and grade of recommendation , according to the Oxford classification 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 r and omly assigned to either single antiplatelet therapy ( aspirin 100 mg ) or a combination of antiplatelet and anticoagulation therapy ( target INR : 2.0 - 3.0 ; mean 2.4±0.3 ) 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 3.9±2.0 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 Introduction The current mainstay of the treatment of thrombotic antiphospholipid syndrome ( APS ) is long-term anticoagulation with vitamin K antagonists ( VKAs ) such as warfarin . Non-VKA oral anticoagulants ( NOACs ) , which include rivaroxaban , have been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism ( VTE ) in major phase III prospect i ve , r and omized controlled trials ( RCTs ) , but the results may not be directly generalizable to patients with APS . Aims The primary aim is to demonstrate , in patients with APS and previous VTE , with or without systemic lupus erythematosus ( SLE ) , that the intensity of anticoagulation achieved with rivaroxaban is not inferior to that of warfarin . Secondary aims are to compare rates of recurrent thrombosis , bleeding and the quality of life in patients on rivaroxaban with those on warfarin . Methods Rivaroxaban in antiphospholipid syndrome ( RAPS ) is a phase II/III prospect i ve non-inferiority RCT in which eligible patients with APS , with or without SLE , who are on warfarin , target international normalized ratio ( INR ) 2.5 for previous VTE , will be r and omized either to continue warfarin ( st and ard of care ) or to switch to rivaroxaban .  Intensity of anticoagulation will be assessed using thrombin generation ( TG ) testing , with the primary outcome the percentage change in endogenous thrombin potential ( ETP ) from r and omization to day 42 . Other TG parameters , markers of in vivo coagulation activation , prothrombin fragment 1.2 , thrombin antithrombin 
    Output:
    
There is not enough evidence for or against NOACs or for high-intensity VKA compared to the st and ard VKA therapy in the secondary prevention of thrombosis in people with APS .
There is some evidence of harm for high-intensity VKA regarding minor and any bleeding .
The evidence was also not sufficient to show benefit or harm for VKA plus antiplatelet agent or dual antiplatelet therapy compared to a single antiplatelet drug .