Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FARM57W8MN
Study information
Scientific title
A randomised study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins
Acronym
ACCEPT-D
Study hypothesis
To assess the effects of low dose aspirin on the incidence of major vascular events, in a wide range of people with type one or type two diabetes with no clinical evidence of vascular disease and receiving statins treatment.
Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 12/03/2007
Initial anticipated end date: 12/09/2013
Ethics approval
Added 11/02/2009: Ethics Committee of the A.S.O. San Luigi Gonzaga, Orbassano (Italy) gave approval on the 2nd April 2007 (ref: 8143)
Study design
Open-label randomised parallel-group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type one and two diabetes mellitus
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Aspirin, simvastatin
Primary outcome measures
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
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)
Overall trial start date
22/10/2007
Overall trial end date
30/04/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5170
Participant 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
Recruitment start date
22/10/2007
Recruitment end date
30/04/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Department of Clinical Pharmacology and Epidemiology
S. Maria Imbaro
66030
Italy
Sponsor information
Organisation
Consortium Mario Negri South (Consorzio Mario Negri Sud) (Italy)
Sponsor details
Via Nazionale
8/a
S. Maria Imbaro
66030
Italy
+39 (0)872 570260
accept-d@negrisud.it
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Italian Ministry of Health (Italy) - public funding grant received
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/17725825
Publication citations
-
Study protocol
De Berardis G, Sacco M, Evangelista V, Filippi A, Giorda CB, Tognoni G, Valentini U, Nicolucci A, , 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., Trials, 2007, 8, 21, doi: 10.1186/1745-6215-8-21.