Risk Assessment and Application of Antithrombotic Therapy in Elderly Patients With Cardiovascular Disease: A Multicenter, Prospective Cohort Study

What this Trial Is About

This research aims to evaluate the effectiveness and safety of two different doses of aspirin, 50 mg daily versus 100 mg daily, for secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in Chinese patients aged 60 years and older. The study addresses the uncertainty of the optimal aspirin dose in elderly Chinese patients, who have unique risk factors and treatment responses compared to Western populations. It builds upon the existing LAPIS cohort, which has enrolled thousands of participants receiving long-term aspirin therapy. Participants are categorized into two groups based on their stable aspirin dose of either 50 mg or 100 mg daily, maintained for at least one year. This is a multicenter, prospective observational cohort study without assigned interventions. The study includes a 2-year extension follow-up, adding to previous LAPIS study data, for a total follow-up of up to approximately 6 years. Follow-ups occur regularly at 1, 3, and 6 months after enrollment and then every 6 months, using telephone, clinic visits, and electronic medical records. During the study, participants will have their cardiovascular events, bleeding episodes, gastrointestinal symptoms, medications, and laboratory tests monitored. The main outcomes measured are the first occurrence of major adverse cardiovascular events (MACE), such as heart attacks and strokes, and bleeding events classified by standard criteria. Data will be collected on demographics, medical history, lab tests, and medication use. An independent committee will review clinical events. The study aims to develop a risk prediction model for thrombotic and bleeding events tailored to elderly Chinese patients on antithrombotic therapy.

Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients