Aspirin and simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes

Conditions

Type one and two diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus

Çelik O, Çil C, Özlek B, Özlek E, Doğan V, Başaran Ö, Demirci E, Bekar L, Kalçık M, Karaarslan O, Yetim M, Doğan T, Demir V, Kalkan S, Özkan B, Hidayet Ş, Taylan G, Küçüksu Z, Çelik Y, Efe SÇ, Aslan O, Biteker M.

2018-12-012 citations

10.14744/anatoljcardiol.2018.47587

Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D): design of a randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins.

De Berardis G, Sacco M, Evangelista V, Filippi A, Giorda CB, Tognoni G, Valentini U, Nicolucci A, ACCEPT-D Study Group.

2007-08-28103 citations

10.1186/1745-6215-8-21

Interventions

Treatment arm: aspirin 100 mg/day per os (orally) until the achievement of the pre-established number of cardiovascular events (515 events

about five years) Control arm: no aspirin given

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent to participate in this study 2. Clinical diagnosis of type one or type two diabetes, irrespective of diabetes treatment 3. Need for statin treatment: 3.1. Patients already receiving statin therapy irrespective of their actual low density lipoprotein (LDL) cholesterol and total cholesterol levels, or 3.2. Patients not currently on statin treatment with LDL cholesterol levels more than or equal to 110 mg/dL persisting after three months of dietary advice 4. Ability and willingness to comply with all study requirements 5. Male and female subjects aged greater than or equal to 50 years

Exclusion criteria

Exclusion criteria: 1. Previous major vascular events (non-fatal myocardial infarction, non-fatal stroke, angina, transient ischaemic attack, revascularisation procedures, peripheral vascular disease) 2. Unstable metabolic control (HbA1c more than 14.0%) 3. Any condition requiring elective treatment with aspirin 4. Contraindications to aspirin 5. Contraindications to simvastatin 6. Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 7. Presence of any life-threatening condition 8. Child-bearing potential (pre-menopausal women not using reliable contraception) 9. History of active substance or alcohol abuse within the last year

Design outcomes

Primary

Measure	Time frame
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 revascularisation procedures, peripheral vascular disease), in a wide range of people with type one or type two diabetes with no clinical evidence of vascular disease and receiving statins treatment.	—

Measure

Time frame

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 revascularisation procedures, peripheral vascular disease), in a wide range of people with type one or type two diabetes with no clinical evidence of vascular disease and receiving statins treatment.

—

Secondary

Measure	Time frame
1. Total and cause specific mortality 2. Venous thromboembolic episodes 3. Major haemorrhagic episodes 4. Total number of hospitalisations for cardiovascular causes (myocardial infarction, stroke, acute coronary syndrome, not planned revascularisation procedures, heart failure, transient ischaemic attack, peripheral vascular disease, lower limb revascularisation procedures)	—

Countries

Italy

Outcome results

None listed