A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

Summary of substantial Protocol amendments Amendment #2 from 09-APR-2008: * Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria * Exclusion of patients currently taking anticoagulant medication * A longer interval between the daily dose of study drug and ibuprofen * Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%." Amendment #3 from 02-JAN-2009 • Increase in the number of allowed risk factors for males, age is no longer a risk factor Amendment #4 from 02-OCT-2013 * The primary endpoint is changed to include confirmed UA and TIA. * The estimated event rate is changed to 1.5% per year due to new information. * Effect size (risk reduction) changed from 14.9% to 17 to 18%. * Achieving 60,000 person-years instead of 1488 primary endpoint events * Additional treatment and follow-up for a maximum of another 12 months. * Change to reduced adverse event and concomitant therapy reporting