A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
Summary of substantial Protocol amendments
Amendment #2 from 09-APR-2008:
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
Inclusion Criteria:
Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
Exclusion Criteria:
Oberaurach, Bavaria 97514, Germany
Sand Am Main, Bavaria 97522, Germany
Lippetal, North Rhine-Westphalia 59510, Germany
Grimma, Thuringia 04668, Germany
Sobrado Dos Monxes, A Coruña 15813, Spain
Posada de Llanes, Principality of Asturias 33594, Spain
Gümar, Santa Cruz De Tenerife 38591, Spain
Newtonabbey, Antrim BT37 9QU, United Kingdom
Tyrone, North Ireland BT80 8BG, United Kingdom
Bury Saint Edmonds, Suffolk IP30 9QU, United Kingdom
Airedire, ML66DB, United Kingdom
Coatrbridge, ML5 3BJ, United Kingdom
New Stevenson, ML1 4LT, United Kingdom
Witley Bay, NE26 1NA, United Kingdom