Aspirin and simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes

Not Applicable

Completed

• Conditions: Type one and two diabetes mellitus; Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN48110081
• Lead Sponsor: Consortium Mario Negri South (Consorzio Mario Negri Sud) (Italy)

Brief Summary

Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/17725825

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-05
• Study Completion: 2015-04-30
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5170

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Total and cause specific mortality<br> 2. Venous thromboembolic episodes<br> 3. Major haemorrhagic episodes<br> 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)<br>