Types 1 and 2 diabetes mellitus. MedDRA version: 6.1 Level: PT Classification code 10012601
Conditions
Interventions
Trade Name: CARDIOASPIRIN*30CPR GAST 100MG
Product Name: ACIDO ACETILSALICILICO
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Acetylsalicylic acid
Current Sponsor code: FARM57W8MN
Sponsors
CONSORZIO MARIO NEGRI SUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent to participate in this study; Clinical diagnosis of type 1 or type 2 diabetes, irrespective of diabetes treatment; Need for statin treatment: - patients already receiving statin therapy irrespective of their actual LDL cholesterol and total cholesterol levels or - patients not currently on statin treatment with LDL-cholesterol levels >=110 mg/dL persisting after three months of dietary advise; Ability and willingness to comply with all study requirements. 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: Previous major vascular events (non-fatal myocardial infarction, non-fatal stroke, angina, transient ischemic attack, revascularization procedures, peripheral vascular disease); Unstable metabolic control (HbA1c >14.0%); Any condition requiring elective treatment with aspirin; Contraindications to aspirin; Contraindications to simvastatin; Chronic therapy with non steroidal antiinflammatory drugs; Presence of any life-threatening condition; Child-bearing potential (pre-menopausal women not using reliable contraception); History of active substance or alcohol abuse within the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of low dose aspirin on the incidence of major vascular events, in a wide range of people with type 1 or type 2 diabetes with no clinical evidence of vascular disease and receiving statins treatment.;Secondary Objective: Total and cause specific mortality, venous thromboembolic episodes, major hemorrhagic episodes, and total number of hospitalizations for cardiovascular causes (myocardial infarction, stroke, acute coronary syndrome, not planned revascularization procedures, heart failure, transient ischemic attack, peripheral vascular disease, lower limb revascularization procedures).;Primary end point(s): To assess the effects of low dose aspirin on the incidence of major vascular events (defined as a combined end-point of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or inpatient or outpatient hospital admission for cardiovascular causes, including acute coronary syndrome, not planned revascularization procedures, peripheral vascular disease), in a wide range of people with type 1 or type 2 diabetes with no clinical evidence of vascular disease and receiving statins treatment. | — |
Countries
Italy
Outcome results
None listed