TCAP--Ticagrelor in Severe Community Acquired Pneumonia

Title: Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia (Short title: TCAP). " Multi-center, prospective randomized placebo controlled double blind, clinical trial " Approximately 568 patients will be enrolled " Participants will be randomized to receive either ticagrelor or placebo " Treatment will continue through 90 days or until death, whichever comes first. Objective: To assess the efficacy and safety of 90 days of oral ticagrelor in patients hospitalized with severe community acquired pneumonia (CAP). Hypothesis: Ticagrelor, compared to placebo, will reduce all-cause 90 day mortality in patients with severe CAP Background: Community acquired pneumonia (CAP) is one of the most common serious infectious diseases in the United States and is an important cause of mortality and morbidity. It is estimated the incidence of CAP in the United States is 5.6 million cases annually, and it is the sixth leading cause of death in people aged >65 years. Mild cases can be treated on an outpatient basis; however, approximately 25% of patients require hospitalization and severe CAP usually results in hospitalization. This study proposes to randomize patients with severe CAP who are > 50 years old who have been admitted to the ICU, to receive ticagrelor or placebo treatment for 90 days to evaluate effects on mortality. Severe CAP will be defined as the presence of new radiographic findings consistent with pneumonia, and admission or plans for admission to an ICU for either severe respiratory distress or to receive vasopressors for hypotension. In addition, patients must have at least two of the following minor criteria: elevated or reduced white blood cell count; elevated or reduced temperature; increased dyspnea; sputum production; and/or a change in the character of sputum.