Children with cardiac diseases suffer from significant morbidity and mortality secondary to thromboembolic complications. Anticoagulant agents currently used for thromboprophylaxis have many limitations, including subcutaneous administration (low molecular weight heparins) and requirement for frequent monitoring via venipuncture (vitamin K antagonists). Edoxaban is an oral direct factor Xa inhibitor without need of monitoring. In the treatment of venous thromboembolism in adults, edoxaban has shown to be effective and safe.

This manuscript summarises the rationale and design of a phase 3, open-label, randomised controlled trial to evaluate and compare the safety and efficacy of edoxaban against standard of care (namely, vitamin K antagonist and low molecular weight heparin) in children with cardiac diseases.

A goal of 150 children with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis will be recruited. Eligible children between 6 months and <18 years of age will be randomised in a ratio of 2 to 1 for edoxaban versus standard of care. Randomisation will be stratified based on underlying cardiac disease and concomitant use of aspirin for patients other than Kawasaki disease. The primary outcome will be safety, comprised of major and clinically relevant non-major bleeding in first 3 months of treatment. Bleeding beyond 3 months, symptomatic and asymptomatic thromboembolic events, and pharmacokinetic and pharmacodynamic parameters will be evaluated as secondary outcomes.

Randomised controlled anticoagulation trials are challenging in children. This study will evaluate a potentially valuable alternative of oral anticoagulant prophylactic use in children with cardiac diseases.

By the 1960s, the urban crisis in the United States was well underway. Structural trans-formations in the postwar economy and accelerating deindustrialization contributed to high rates of unemployment in many cities in the nation's old industrial core. During the 1970s and 1980s, the urban crisis worsened. This article argues that the macroeconomic policies of Presidents Richard Nixon, Jimmy Carter, and Ronald Reagan fueled urban decline. Responding to the waning hegemony of the United States in the global economy as well as to a domestic corporate crisis of profitability, the presidents pursued macroeconomic agendas that prioritized the revitalization of American economic dominance. Macroeconomic policy decisions in combination with white-backlash pressures constrained the range of urban policies the presidents could pursue and often compelled privatization. The federal-level decisionmaking had devastating consequences in Baltimore, Maryland, the city discussed in this article. The macroeconomic and urban policies had racialized and gendered outcomes that plunged the city into the most acute phase of the urban crisis.