• Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Time to first occurrence of the individual components of the primary: MI, stroke or cardiovascular death [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Time to occurrence/ incidence of all cause mortality [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Time to first occurrence/ incidence of all cancers, excluding non melanoma skin cancer [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Time to first occurrence/ incidence of colon cancer [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Incidence of MI, stroke and CV death [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: No ]
• Incidence of treatment-emergent adverse events (observed and reported), and changes in the physical examination findings, weight, and vital signs [ Time Frame: Approximately 5 years (duration of planned treatment phase) ] [ Designated as safety issue: Yes ]

• Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke
• Time to first occurrence of the individual components of the primary: MI, stroke or cardiovascular death
• Time to occurrence/ incidence of all cause mortality
• Time to first occurrence/ incidence of all cancers, excluding non melanoma skin cancer
• Time to first occurrence/ incidence of colon cancer
• Incidence of MI, stroke and CV death
• TIME FRAME for all secondary outcomes: approximately 5 years (duration of planned treatment phase)

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year). The current study is designed to proof 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 (20-30% 10-year) of cardiovascular disease. Subjects are treated in a standard care setting and may receive treatment of 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.

• Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
• Drug: Placebo

Inclusion Criteria:

• Males aged 55 years and above with 2 to 4 risk factors Male Risk Factors

  • Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
  • Current smoking: defined as any cigarette smoking in the past 12 months
  • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
  • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
  • Currently on any medication to treat high blood pressure
  • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)

• Females aged 60 and above with 3 or more risk factors Female Risk Factors

  • Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
  • Current smoking: defined as any cigarette smoking in the past 12 months
  • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
  • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
  • Currently on any medication to treat high blood pressure
  • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
• An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Exclusion Criteria:

• Clinical history of CVD, MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or
• Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
• Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
• Increased risk of bleeding or gastric or duodenal ulcer, or current /diagnosed reflux esophagitis
• Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patients ability to complete the study or precludes the patients participation in the study
• Lactating women or women of childbearing potential
• Severe liver disease or damage, or moderately impaired renal function based on the clinical judgment of the investigator
• A definite indication for acetylsalicylic acid therapy, other anti-platelet drug, or anticoagulant in the opinion of the physician
• A history of asthma induced by administration of salicylates or substances with similar action, notably NSAIDS
• Chronic, frequent (> 5 days/month) use of NSAIDs, COX 2 inhibitors or metamizole, or current participation in any other trials involving investigational products within 30 days prior to the Screening Visit