Patients at moderate risk of CHD events (10-20% 10-year CHD risk
Conditions
Interventions
Trade Name: Aspirin protect 100 mg
Product Name: enteric coated acetylsalicylic acid 100 mg tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: acetylsalicylic acid
Concentration unit
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age - elevated total cholesterol - low HDL cholesterol - elevated blood pressure - family history of early CHD - smoking - on antihypertensive therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - type I and type II diabetes - prior history of a CVD events (clinical or diagnostic) - standard exclusion criterias for ASA (see protocol) - any condition likely to cause death within 5 years - chronic, frequent use of NSAID´s or COX-2 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical effect of a 100 mg/day enteric coated aspirin vs placebo in the reduction of CVD events in patients at moderate risk of CHD events (approx 10 - 20% 10 year-risk). This corresponds to a patient population mean 10-year CVD risk of approx 30% based on the underlying assumption at study start.;Secondary Objective: To evaluate the safety and tolerability of the IMP in the same population.;Primary end point(s): The primary efficacy endpoint will be a composite outcome consisting of a first occurence of confirmed MI, stroke, cardiovascular death, UA, or TIA.;Timepoint(s) of evaluation of this end point: The composite primary endpoint will be evaluated at end of study. In addition, the study will be monitored by an independent Data Safety Monitoring Board (DSMB) at regular intervals during the course of the study. The DSMB will review all data to ensure the safety of patients, which they will do by analyzing adverse events and by performing interim analyses of the clinical outcome data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In addition, the following parameters will be used to assess the efficacy of the study drug: • A composite outcome of the time to the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) • Time to the first non-fatal MI • Time to the first MI (fatal or non-fatal) • Time to first occurrence of a non-fatal stroke • Time to first occurrence of fatal or non-fatal stroke Analyses will also be presented for ischemic and hemorrhagic stroke separately, if appropriate. • Time to cardiovascular death • Time to the first occurrence of UA • Time to the first occurrence of TIA • Time to / incidence of all-cause mortality • Time to first occurrence of / incidence of all cancers excluding nonmelanoma skin cancer • Time to first occurrence of / incidence of colon cancer • Incidence of confirmed MI, stroke, cardiovascular death, UA, and TIA separately;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at end of study. In addition, the study will be monitored by an independent Data Safety Monitoring Board (DSMB) at regular intervals during the course of the study. The DSMB will review all data to ensure the safety of patients, which they will do by analyzing adverse events and by performing interim analyses of the clinical outcome data. | — |
Countries
Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed