Patients were randomized to receive either oral rivaroxaban 10 mg once daily for 31 to 39 days with placebo injection, beginning 6 to 8 hours after wound closure, or subcutaneous. The record 3 trial which demonstrated the rivaroxabans efficacy for prevention of vte in patients undergoing knee replacement surgery is heavily supported by the record 1 and 2 trials and to an. The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability. Group 1 evaluated rivaroxaban 15 mg daily and clopidogrel monotherapy resembles the woest trial. Results of prespecified pooled analyses a pooled analysis was performed on the record 1, 2 and 3 trials n 9581, which used the same comparator regimen. Rivaroxaban, sold under the brand name xarelto among others, is an anticoagulant medication blood thinner used to treat and prevent blood clots. Representativeness of the dabigatran, apixaban and. The record programme compared the efficacy and safety of oral rivaroxaban with subcutaneous subcutaneous introduced beneath the skin. The record1 and 3 trials are published in the june 26, 2008, issue of the new england journal of medicine 1,2, while the record2 trial is published online in the lancet on june 25, 2008. Objective three oral anticoagulants have reported study results for stroke prevention in patients with atrial fibrillation af dabigatran etexilate, rivaroxaban and apixaban. Rivaroxabans impact on renal decline in patients with. Rivaroxaban versus enoxaparin for thromboprophylaxis after. P 2008 trial summary pdf trial summary a randomised clinical trial investigating the effect of rivaroxaban versus enoxaparin in patients undergoing total hip arthroplasty.
Rivaroxaban is noninferior to standard therapy of enoxaparin and vitamin k antagonist in treating acute, symptomatic deepvein thrombosis. They report that the four phase 3 record trials together compared rivaroxaban with enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty in more than 12 500 patients. Rivaroxaban versus enoxaparin for thromboprophylaxis after total. Validity of pivotal rocket af rivaroxaban trial questioned. Patients for whom the decision was made to start rivaroxaban for treatment of dvt and or pe and or prevention of recurrent dvt and pe. Record1 and record2 and elective total knee arthroplasty tka. A study that administered multiple doses of rivaroxa ban ranging. This study aimed to assess the representativeness for the realworld af population, particularly the population. In summary, record 1 and 2 trials provide the support for the use of rivaroxaban in patients undergoing hip replacement surgery. In the study, patients were randomized to receive either rivaroxaban 2.
Late in 2011, rivaroxaban became the first factor xa inhibitor to receive regulatory approval for the prevention of stroke in patients with atrial fibrillation af, based largely on the results of the phase iii rocket af rivaroxaban oncedaily, oral, direct factor xa inhibition compared with vitamin k antagonism for prevention of stroke and embolism trial in atrial fibrillation trial. The trial design was complex and warrants a summary. The results of the trial show that those who received either lowdose rivaroxaban plus a p2y 12 inhibitor for 12 months or verylowdose rivaroxaban plus dual antiplatelet therapy dapt for one, six or 12 months had lower rates of significant bleeding compared with the standard therapy group. We sought to compare rivaroxaban and warfarins impact on renal decline in patients with nonvalvular atrial fibrillation nvaf treated in routine practice. Pharmacodynamic and pharmacokinetic basics of rivaroxaban. Xarelto rivaroxaban tablets, for oral use initial u. Rivaroxaban rocket af record3 record4 record1 record2 enstein dvt enstein pe enstein continued treatment atlas timi 51 magellan apixaban aristotle averroes advance1 advance2 advance3 amplify amplifyext appraise2 adopt nonbolded studies are for offlabel indications redeem was a phase 2 study methods. The very large compass study has been stopped early for overwhelming efficacy, according to a press release issued by bayer ag and janssen, manufacturers of rivaroxaban xarelto. Enormous rivaroxaban study stopped early for overwhelming. Randomized, doubleblind, clinical trial comparing the efficacy and safety of xarelto with enoxaparin for dvt prophylaxis in patients undergoing hip replacement surgery.
Full text rivaroxaban for venous thromboembolism prevention after. Using us marketscan claims data from january 2012 to december 2017, we identified patients with nvaf newly initiated on rivaroxaban or warfarin with. It also compared dual therapy with rivaroxaban to triple therapy with warfarin. Aegis ii executive committee funded by csl behring, belvoir. The primary efficacy outcome for each study was dvt symptomatic or. In the record2 study, to investigate the benefits of an extended treatment regimen in the prevention of vte in patients undergoing elective total hip replacement. Major bleeding from a gastrointestinal site was more common in the rivaroxaban group, with 224 bleeding events 3. The record 2 trial included 2,509 patients undergoing tha that were assigned to receive either rivaroxaban 10 mg daily for 39 days or enoxaparin 40 mg daily for 1014 days.
The auc of rivaroxaban is increased by 50% and the t1. Patients who are willing to participate in this study signed informed consent. The largest study to date the pepper trial which is powered to show differences in vte plus mortality is ongoing. In this trial, rivaroxaban was associated with a 12% reduction in the incidence of the primary endpoint compared with warfarin hazard ratio 0. The volume of distribution is moderate approximately 50 l at steady state. P rivaroxaban once daily for 39 days, with placebo injection for 10. Extended duration rivaroxaban versus shortterm enoxaparin. Randomized, phase 3, multicenter, openlabel, parallelgroup, activecontrolled, eventdriven, noninferiority studies einstein dvt and einstein pe with patients receiving xarelto at an initial dose of 15 mg twice daily with food for the first 3 weeks, followed by xarelto 20 mg once daily with food or enoxaparin 1 mgkg twice daily for at least 5 days. The record 2 trial did demonstrate an increase in cardiovascular adverse events after rivaroxaban was discontinued, suggesting the possibility of rebound activation of coagulation. Because of low numbers, investigators could not determine if the result was due to chance. Rivaroxaban for thromboprophylaxis after hospitalization. A total of 2124 participants were randomized to one of the following three treatment groups.
Pdf the discovery and development of rivaroxaban, an. Patients with eastern cooperative oncology group ecog performance status score of 0, 1 or 2. Record4 regulation of coagulation in orthopaedic surgery to prevent deep vein thrombosis and pulmonary embolism is a multicentre, randomised, doubleblind trial designed to assess the efficacy and safety of oral rivaroxaban 10 mg once daily compared with 30 mg enoxaparin given subcutaneously every 12 h, for the prevention of venous thromboembolism after elective total knee arthroplasty. About the record clinical trial program bayer investor relations. The participant exclusion criteria have been changed. My cardiologist recommended xarelto because of age 83 and i experienced a fib one time. A complete analysis of the data from the compass trial is expected to be presented at a medical meeting in 2017. Rivaroxaban, a new oral factor xa inhibitor, provides new. The risk of major and clinically relevant nonmajor bleeding was not significantly different when comparing rivaroxaban with standard therapy. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip. However, despite the promising results of the atlas acs timi 46 trial, a triple combination of. An openlabel, randomized, controlled, multicenter study. Design, findings and implications of the record study program.
Specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent blood clots in atrial fibrillation and following hip or knee surgery. The trial hypothesis was that rivaroxaban would be superior to placebo for the prevention of the primary efficacy outcome. Record 2, 2008 trial summary pdf trial summary a randomised clinical trial investigating the effect of rivaroxaban long duration versus enoxaparin short duration in. In this randomized, doubleblind study, we assigned 4541 patients to. The phase 3 trial randomized 27,402 patients with coronary artery disease cad and peripheral artery disease pad to receive either rivaroxaban 2. The record 2 trial included 2,509 patients undergoing tha that. The new oral anticoagulants blood american society of. First data unveiled from callisto program examining the. Many of these issues are difficult to study in randomized.
Jenny phillips has been removed from the trial contacted and jaclyn brown added. Rivaroxaban for the prevention of venous thromboembolism. Dvt prophylaxis clinical trials xarelto rivaroxaban. Extended duration rivaroxaban versus shortterm enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty. Rivaroxaban oncedaily oral direct factor xa inhibition compared with vitamin k antagonism for prevention of stroke and embolism trial in atrial fibrillation 22. In this randomized, doubleblind 16 000patient trial, 2 doses of rivaroxaban 2.
1009 1622 339 409 160 263 1095 685 523 1114 429 246 597 30 881 80 1084 1545 664 34 1010 1534 1154 75 1188 21 116 556 738 1382 295 1297 1381 552 1224