About the record clinical trial program bayer investor relations. The participant exclusion criteria have been changed. 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 record 2 trial did demonstrate an increase in cardiovascular adverse events after rivaroxaban was discontinued, suggesting the possibility of rebound activation of coagulation. Major bleeding from a gastrointestinal site was more common in the rivaroxaban group, with 224 bleeding events 3. Record 2, 2008 trial summary pdf trial summary a randomised clinical trial investigating the effect of rivaroxaban long duration versus enoxaparin short duration in. Because of low numbers, investigators could not determine if the result was due to chance. 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.
Full text rivaroxaban for venous thromboembolism prevention after. 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. A study that administered multiple doses of rivaroxa ban ranging. Bleeding rates were higher in both treatment arms for those with any recall condition, with a trend toward a higher relative risk of major bleeding with. In this randomized, doubleblind study, we assigned 4541 patients to.
The auc of rivaroxaban is increased by 50% and the t1. 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. Representativeness of the dabigatran, apixaban and. Rivaroxaban for the prevention of venous thromboembolism. Extended duration rivaroxaban versus shortterm enoxaparin. Randomized, doubleblind, clinical trial comparing the efficacy and safety of xarelto with enoxaparin for dvt prophylaxis in patients undergoing hip replacement surgery. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip. In this randomized, doubleblind 16 000patient trial, 2 doses of rivaroxaban 2. Pdf rivaroxaban and the einstein clinical trial programme.
Rivaroxaban is noninferior to standard therapy of enoxaparin and vitamin k antagonist in treating acute, symptomatic deepvein thrombosis. 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. Pdf the discovery and development of rivaroxaban, an. The trial hypothesis was that rivaroxaban would be superior to placebo for the prevention of the primary efficacy outcome. A complete analysis of the data from the compass trial is expected to be presented at a medical meeting in 2017. 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. The risk of major and clinically relevant nonmajor bleeding was not significantly different when comparing rivaroxaban with standard therapy. Jenny phillips has been removed from the trial contacted and jaclyn brown added.
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. This study aimed to assess the representativeness for the realworld af population, particularly the population. 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. In the study, patients were randomized to receive either rivaroxaban 2. The new oral anticoagulants blood american society of. Enormous rivaroxaban study stopped early for overwhelming. Dvt prophylaxis clinical trials xarelto rivaroxaban. Using us marketscan claims data from january 2012 to december 2017, we identified patients with nvaf newly initiated on rivaroxaban or warfarin with. I started the drug 20mg and on the second day i had a fib and my heart rate was 104 and two days later another a fib with heart rate of 105 and on the fourth day a fib and heart rate at 104 again. Rivaroxaban, a direct oral anticoagulant, is widely used for. Rivaroxaban, sold under the brand name xarelto among others, is an anticoagulant medication blood thinner used to treat and prevent blood clots. P 2008 trial summary pdf trial summary a randomised clinical trial investigating the effect of rivaroxaban versus enoxaparin in patients undergoing total hip arthroplasty. Validity of pivotal rocket af rivaroxaban trial questioned. Rivaroxaban, a new oral factor xa inhibitor, provides new.
Group 1 evaluated rivaroxaban 15 mg daily and clopidogrel monotherapy resembles the woest trial. The volume of distribution is moderate approximately 50 l at steady state. Aegis ii executive committee funded by csl behring, belvoir. The largest study to date the pepper trial which is powered to show differences in vte plus mortality is ongoing. Extended duration rivaroxaban versus shortterm enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty. Objective three oral anticoagulants have reported study results for stroke prevention in patients with atrial fibrillation af dabigatran etexilate, rivaroxaban and apixaban. Many of these issues are difficult to study in randomized. 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. The bioavailability of a 10 mg dose of rivaroxaban is high 80100%, and rivaroxaban is rapidly absorbed, reaching a maximal plasma concentration c max within 24 h after oral administration 3, 6. A noninterventional study on xarelto for treatment of. My cardiologist recommended xarelto because of age 83 and i experienced a fib one time. The record programme compared the efficacy and safety of oral rivaroxaban with subcutaneous subcutaneous introduced beneath the skin. Record1 and record2 and elective total knee arthroplasty tka. Design, findings and implications of the record study program.
Xarelto rivaroxaban tablets, for oral use initial u. Pharmacodynamic and pharmacokinetic basics of rivaroxaban. We sought to compare rivaroxaban and warfarins impact on renal decline in patients with nonvalvular atrial fibrillation nvaf treated in routine practice. In summary, record 1 and 2 trials provide the support for the use of rivaroxaban in patients undergoing hip replacement surgery.
Rivaroxabans impact on renal decline in patients with. 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. 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. Rivaroxaban versus enoxaparin for thromboprophylaxis after. 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. Patients with eastern cooperative oncology group ecog performance status score of 0, 1 or 2. A total of 2124 participants were randomized to one of the following three treatment groups. The trial design was complex and warrants a summary. An openlabel, randomized, controlled, multicenter study. Bioequivalence study of rivaroxaban full text view. P rivaroxaban once daily for 39 days, with placebo injection for 10. 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. In this trial, rivaroxaban was associated with a 12% reduction in the incidence of the primary endpoint compared with warfarin hazard ratio 0.
The record 2 trial included 2,509 patients undergoing tha that. Rivaroxaban oncedaily oral direct factor xa inhibition compared with vitamin k antagonism for prevention of stroke and embolism trial in atrial fibrillation 22. Triple therapy with rivaroxaban reduces bleeding compared. 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. Rivaroxaban for thromboprophylaxis after hospitalization. The pioneerafpci trial is the largest rct n2124 to date comparing triple therapy with warfarin vs a doac i. It also compared dual therapy with rivaroxaban to triple therapy with warfarin. 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 is also being studied in a phase 3 trial of patients with recent acute coronary syndrome. The primary efficacy outcome for each study was dvt symptomatic or. 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 phase 3 trial randomized 27,402 patients with coronary artery disease cad and peripheral artery disease pad to receive either rivaroxaban 2. The combined incidence of major and clinically relevant nonmajor bleeding events was 3. First data unveiled from callisto program examining the.
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