Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/01/2007
Date assigned
05/03/2007
Last edited
11/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Nicolucci

ORCID ID

Contact details

Department of Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale
8/a
S. Maria Imbaro
66030
Italy

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

http://www.negrisud.it

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

  1. 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.

Additional files

Editorial Notes