A randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins. - ACCEPT-D

• Conditions: Types 1 and 2 diabetes mellitus.; MedDRA version: 6.1Level: PTClassification code 10012601

• Registration Number: EUCTR2007-000183-24-IT
• Lead Sponsor: CONSORZIO MARIO NEGRI SUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified