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ISRCTN
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ISRCTN48110081
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ClinicalTrials.gov identifier
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Public title
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Aspirin and simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes
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Scientific title
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A randomised study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins
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Acronym
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ACCEPT-D
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Serial number at source
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FARM57W8MN
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Study hypothesis
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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
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Lay summary
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Ethics approval
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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)
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Study design
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Open-label randomised parallel-group study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Type one and two diabetes mellitus
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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22/10/2007
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Anticipated end date
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30/04/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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5170
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Italian Ministry of Health (Italy) - public funding grant received
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Trial website
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Publications
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Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/17725825
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Contact name
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Dr
Antonio
Nicolucci
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Address
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Department of Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale, 8/a
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City/town
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S. Maria Imbaro
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Zip/Postcode
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66030
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Country
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Italy
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Sponsor
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Consortium Mario Negri South (Consorzio Mario Negri Sud) (Italy)
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Address
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Via Nazionale, 8/a
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City/town
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S. Maria Imbaro
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Zip/Postcode
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66030
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Country
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Italy
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Tel
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+39 (0)872 570260
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Fax
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+39 (0)872 570263
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Email
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accept-d@negrisud.it
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Sponsor website:
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http://www.negrisud.it
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Date applied
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18/01/2007
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Last edited
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11/02/2009
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Date ISRCTN assigned
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05/03/2007
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