Limitations
EVENTS
There are several limitations to address. First, although our results may provide a reference for anticoagulant care in patients with ACS in the acute phase, all patients included in this study were Chinese, which could limit the generalizability of the findings to patients of different nationalities and races. Further studies with other cohorts of patients with ACS of different nationalities and races are needed. Second, this study was a feasibility randomized equivalence and noninferiority trial to demonstrate the potential safety and efficacy of rivaroxaban vs enoxaparin in patients with ACS. Although some end point events between groups reached noninferiority, the power was low due to small sample size. A planned future trial with a sample size of 5655 for each group will aim to address these questions. Third, the use of a 6-month time window in noninferiority assessment of safety and efficacy of an antithrombotic trial regimen given for the first 4 days only may increase the false-positive rate (α error) in the trial, as the addition of events that do not bear on the randomized treatment may increase the power of the trial. However, future trials may select primary end points in a short-term follow-up (eg, 1 month), while the sample size may increase exponentially with a lower incidence of events. Fourth, the use of an open-label study may have introduced some degree of bias related to the patients and physicians not being blinded to the assigned treatment. We attempted to minimize any potential bias by having all clinical events reviewed and adjudicated by an independent clinical events committee. Fifth, although the use of ticagrelor or prasugrel is not currently recommended as part of triple antithrombotic therapy with aspirin and oral anticoagulant,