Date: 2011-11-13
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: presentation of results at the American Heart Association Scientific Sessions
Company: Bayer HealthCare (Germany)
Product: Xarelto® (rivaroxaban)
Action
mechanism: anticoagulant agent/oral direct Factor Xa inhibitor
Disease: Secondary Prevention of Acute Coronary Syndrome (ACS)
Therapeutic
area: Cardiovascular diseases
Country:
Trial
details:
- The ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) study was designed to test the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, myocardial infarction and stroke in patients with ACS. Patients were given standard antiplatelet therapy plus rivaroxaban dosed at 2.5 mg or 5 mg BID, or a placebo. Of the 15,526 patients randomized into the study, 93% received aspirin and thienopyridine in addition to rivaroxaban or placebo, and the balance were treated with aspirin plus rivaroxaban or placebo.
- The double blind, randomized, placebo-controlled study was coordinated by the TIMI Study Group and Brigham and Women’s Hospital and Harvard Medical School, and was funded and led by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development.
Latest
news:
- Bayer HealthCare announced that the combination of oral Xarelto® (Rivaroxaban) twice daily with standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome (ACS) compared to those receiving standard antiplatelet therapy alone. In addition, rivaroxaban 2.5 mg in combination with standard therapy significantly reduced mortality over standard therapy alone. Results from the pivotal Phase III ATLAS ACS 2-TIMI 51 study presented and published by the New England Journal of Medicine also showed that rivaroxaban significantly increased the rate of major bleeding, but did not increase the risk of fatal bleeding over standard therapy alone.
- The results of the ATLAS ACS 2-TIMI 51 study showed that both 2.5 and 5 mg of rivaroxaban dosed twice daily (BID) in addition to standard therapy — low-dose aspirin with or without a thienopyridine such as clopidogrel — were superior to standard therapy plus placebo in both study arms in the primary efficacy endpoint of preventing recurrent major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in patients with ACS [combined doses 8.9% vs. 10.7% (1) (P=0.008), Relative Risk Reduction (RRR)=16%]. Additionally and importantly, rivaroxaban significantly reduced stent thrombosis compared with placebo [2.3% vs. 2.9% (P=0.016)].
- Patients dosed with 2.5 mg BID of rivaroxaban showed a significant reduction in risk of the composite primary endpoint [9.1% vs. 10.7% (P=0.020)], driven by a significant 34% RRR in the rate of cardiovascular death [2.7% vs. 4.1% (P=0.002)]. There was also a significant reduction in deaths from any cause [2.9% vs. 4.5% (P=0.002)]. The 5 mg BID dose of rivaroxaban also significantly reduced the rate of the primary efficacy endpoint in the study [8.8% vs. 10.7% (P=0.028)].
- The principal safety endpoint for the study was TIMI major bleeding not associated with coronary artery bypass graft (CABG) surgery. In patients receiving rivaroxaban in combination with standard therapy, bleeding rates were statistically significantly increased versus those treated with standard therapy plus placebo [2.1% vs. 0.6% (P<0.001)]. Similarly, rivaroxaban resulted in higher rates of TIMI major bleeding events not associated with CABG surgery at both the 2.5 mg and 5 mg BID doses compared to placebo [1.8% vs. 0.6% (P<0.001) and 2.4% vs. 0.6% (P<0.001), respectively]. Importantly, rivaroxaban did not increase the risk of fatal bleeding. Other treatment-emergent adverse events were generally balanced across treatment groups.
The FDA has granted rivaroxaban "fast track" designation for this indication, given the seriousness of ACS as a medical condition and the potential clinical benefit of rivaroxaban.
Is
general: Yes
