Aspirin and simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes

ISRCTN	ISRCTN48110081
DOI	https://doi.org/10.1186/ISRCTN48110081
Secondary identifying numbers	FARM57W8MN

Submission date: 18/01/2007
Registration date: 05/03/2007
Last edited: 24/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Antonio Nicolucci
Scientific

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

Study information

Study design	Open-label randomised parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	ACCEPT-D
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Aspirin, simvastatin
Primary outcome measure	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 study start date	22/10/2007
Completion date	30/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	5170
Key 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
Key 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
Date of first enrolment	22/10/2007
Date of final enrolment	30/04/2015

Locations

Countries of recruitment

Italy

Study participating centre

Department of Clinical Pharmacology and Epidemiology

S. Maria Imbaro
66030
Italy

Sponsor information

Consortium Mario Negri South (Consorzio Mario Negri Sud) (Italy)
Research organisation

Via Nazionale, 8/a
S. Maria Imbaro
66030
Italy

Phone	+39 (0)872 570260
Email	accept-d@negrisud.it
Website	http://www.negrisud.it
"ROR"	https://ror.org/01qd3xc93

Funders

Funder type

Government

Italian Ministry of Health (Italy) - public funding grant received

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Study protocol	28/08/2007		Yes	No

Editorial Notes

24/07/2020: No publications found.