Rationale and Design of a Study to Assess the Engagement and Usefulness of the Care4Today Connect Digital Health Application for Disease Management in Coronary Artery Disease and Peripheral Artery Disease (iPACE-CVD Study).

Introduction: Coronary artery disease (CAD) and peripheral artery disease (PAD) increase the risks of cardiovascular events and death. Digital health technologies are rapidly expanding to improve healthcare quality and access. The Care4Today Connect (C4T CAD-PAD) mobile application is designed to help patients with CAD and/or PAD improve medication adherence, learn about their disease, make lifestyle modifications, and enhance healthcare provider (HCP) connection via an HCP-facing portal.

Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

Background: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown.

Methods: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days.

Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.

Background: Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established.

Methods: This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients.

Assessing Full Benefit of Rivaroxaban Prophylaxis in High-Risk Ambulatory Patients with Cancer: Thromboembolic Events in the Randomized CASSINI Trial.

 In the CASSINI study, rivaroxaban thromboprophylaxis significantly reduced primary venous thromboembolism (VTE) endpoints during the intervention period, but several thromboembolic events designated as secondary efficacy endpoints were not included in the primary analysis. This study was aimed to evaluate the full impact of rivaroxaban thromboprophylaxis on all prespecified thromboembolic endpoints occurring on study.  CASSINI was a double-blind, randomized, placebo-controlled study in adult ambulatory patients with cancer at risk for VTE (Khorana score ≥2).

Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.

Background: Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.

Methods: In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks.

A double-blind, randomized comparison of levofloxacin 750 mg once-daily for five days with ciprofloxacin 400/500 mg twice-daily for 10 days for the treatment of complicated urinary tract infections and acute pyelonephritis.

Objectives: A clinical study was conducted to compare the efficacy and safety of levofloxacin 750 mg once daily for 5 days to ciprofloxacin twice daily for 10 days for the treatment of complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).

Methods: A multicenter, double-blind, randomized, noninferiority study enrolled subjects with AP or cUTI. Subjects received either levofloxacin 750 mg intravenously or orally once daily for 5 days or ciprofloxacin 400 mg intravenously and/or ciprofloxacin 500 mg orally twice daily for 10 days and were evaluated at end of therapy, posttherapy, and poststudy for microbiologic eradication and clinical outcome.

Identification and pretherapy susceptibility of pathogens in patients with complicated urinary tract infection or acute pyelonephritis enrolled in a clinical study in the United States from November 2004 through April 2006.

Objective: The purpose of this study was to assess the pretherapy microbiology and fluoroquinolone susceptibility of pathogens from 650 patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) as part of a multicenter, randomized, controlled clinical trial.

Methods: In this post hoc analysis of a multicenter, randomized, double-blind study, adults with a clinical diagnosis of cUTI or AP were recruited from 130 community-based and institution-based study centers in the United States from November 2004 through April 2006. Urine and blood culture specimens were identified and tested for susceptibility according to Clinical and Laboratory Standards Institute methods.

A trial of levofloxacin 750 mg once daily for 5 days versus ciprofloxacin 400 mg and/or 500 mg twice daily for 10 days in the treatment of acute pyelonephritis.

Objective: A double-blind, noninferiority trial was conducted to establish the safety and efficacy of a once-daily, 5-day course of levofloxacin 750 mg compared to a twice-daily, 10-day course of ciprofloxacin in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). This report focuses on subjects with AP.

Research Design And Methods: Adult male and female subjects with clinical signs and symptoms of AP and laboratory confirmation of their diagnosis were randomized to receive one dose of levofloxacin 750 mg once daily intravenously (i.