A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Condition: Moderate Risk of CVD
MeSH terms: Cardiovascular Diseases
Intervention: Aspirin (Acetylsalicylic acid, BAYE4465); Placebo
Intervention description: 100mg enteric coated Aspirin, taken daily; Placebo, taken daily
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12546.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Primary prevention of coronary heart disease; Stroke and cardiovascular death; Aspirin

Summary:

      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.
    

Eligibility criteria:

        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:

          -  History of a documented vascular event, such as MI, stroke, coronary artery
             angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or
             congestive heart failure or vascular intervention

          -  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

          -  Recent (in the past year) history of gastrointestinal or genitourinary bleeding or
             other bleeding disorders

          -  Active diagnosed and documented 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 patient's
             ability to complete the study or precludes the patient's participation in the study

          -  Lactating women or women of childbearing potential

          -  Severe liver disease or damage based on the clinical judgment of the investigator

          -  Severe renal disease or damage based on the clinical judgement of the investigator

          -  A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or
             anticoagulant in the opinion of the physician

          -  A history of asthma induced by administration of salicylates or substances with a
             similar action, notably NSAIDS

          -  Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin
             containing products), COX-2 inhibitors or metamizole

          -  Current participation in any other trials involving investigational products within 30
             days prior to the Screening Visit

          -  Current use of an anticoagulant medication

          -  Sitting systolic blood pressure greater than 170 mmHg