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| Randomised controlled trial of low dose Aspirin in the prevention of cardiovascular events and death in subjects with Asymptomatic Atherosclerosis |
| Source of record | UK Trials |
| ISRCTN | ISRCTN66587262 |
| Date ISRCTN assigned | 31/01/2002 |
| Local reference number(s) | RG/97006; 057762 |
| Public title | Randomised controlled trial of low dose Aspirin in the prevention of cardiovascular events and death in subjects with Asymptomatic Atherosclerosis |
| Scientific title | |
| Acronym | AAA Trial |
| Disease/condition/study domain | Cardiovascular disease, cognitive decline |
| Study hypothesis | Primary prevention strategies aimed at modifying cardiovascular risk factors in otherwise healthy individuals have proved of only limited benefit in the primary prevention of cardiovascular disease. It is possible to identify in the general population large numbers of subjects with asymptomatic preclinical atherosclerosis who are at high risk of subsequent cardiovascular events using a simple blood pressure measurement - the Ankle Brachial Pressure Index (ABPI). We are currently conducting the first prevention trial on such high-risk subjects to determine whether low dose aspirin can reduce the incidence of cardiovascular events and death. 3,350 subjects aged over 50 years with an ABPI of at least 0.95 but no history of cardiovascular disease have been randomised into this double-blind placebo-controlled trial. The principal hypothesis is that treatment of subjects with asymptomatic atherosclerosis, using low-dose aspirin, prevents subsequent cardiovascular disease indicated by incidence of major cardiovascular and cerebrovascular events. An additional endpoint was added to this trial shortly after funding was obtained for the original AAA trial. As this additional endpoint has little to do with cardiovascular disease, funding was sought, and gained, from the Wellcome Trust. This end point was known as the ¿Randomised controlled trial of aspirin in the reduction of age associated cognitive decline¿, and any information relating only to this endpoint will be headed with the title: ¿Cognitive decline endpoint¿ The aim of this endpoint is to determine whether low dose aspirin treatment over a five-year period reduces cognitive decline in subjects at high risk of cardiovascular disease. |
| Design/methodology | Randomised, placebo-controlled trial |
| Research ethics review | AAA Trial: 1. Lanarkshire Research Ethics Committee: date of approval 22/04/1997 (ref: ER/4/97/8) 2. Greater Glasgow Community/Primary Care Local Research Ethics Committee: date of approval 14/06/1999 (ref: 45A/99) 3. Lothian Research Ethics Committee: date of approval 31/05/1999 (ref: 1702/99/3/23) Cognitive Study: 1. Lanarkshire Research Ethics Committee: date of approval 26/10/1999 (ref: ER/49/10/99) 2. Greater Glasgow Community/Primary Care Local Research Ethics Committee: details as for AAA Trial (see above) 3. Lothian Research Ethics Committee: amendment to AAA Trial made and approved on 11/10/1999 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Men and women aged between 50 and 80 years 2. Ankle brachial pressure index 0.95 or less in at least one limb 3. Living in central Scotland (Lothian, Greater Glasgow and Lanarkshire) 4. No history of clinical cardiovascular disease |
| Participants - exclusion criteria | 1. Receiving aspirin and/or other anticoagulants 2. Contraindication to aspirin therapy |
| Patient information material | |
| Anticipated start date | 01/04/1998 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 3350 (recruitment ended as of 1st February 2002) |
| Interventions | 100 mg enteric-coated aspirin daily for five years or placebo daily for five years The trials were initially designed to end simultaneously, but follow-up in the AAA Trial has been extended (with corresponding supplementary funding from BHF and CSO) to obtain the required number of major cardiovascular endpoints. Similar power considerations were not necessary for the cognitive decline endpoint; therefore the end date for the cognitive decline endpoint is 31st April 2006. Public contact for the cognitive decline endpoint: Dr Jackie Price Community Health Sciences University of Edinburgh Medical School Teviot Place Edinburgh EH8 9AG United Kingdom Tel: +44 (0)131 650 3240 Fax: +44 (0)131 650 6904 Email: Jackie.Price@ed.ac.uk |
| Primary outcome measure(s) | Myocardial infarction and stroke (fatal and non-fatal) or revascularisation Cognitive decline endpoint: A detailed battery of tests was administered to assess a broad range of the participants¿ cognitive functions. The test battery was administered in a quiet room either in the clinic or at the patient¿s home by a trained researcher. The order of tests in the battery was predetermined. The Mini Mental State Examination (MMSE) was included as a general mental assessment and as a ¿screen¿ for dementia. Executive function was assessed with use of the Verbal Fluency Test, which requires participants to generate as many words as possible with a specified initial letter (C, F and L). As a measure of non-verbal reasoning, participants were asked to work through all five sets (A to E) of the Raven¿s Progressive Matrices, and were scored according to the number of items they completed correctly within 20 minutes. Immediate and delayed memory was assessed using a participant¿s total score on the first five trials (I through V) of the Auditory Verbal Learning Test. As a measure of mental flexibility, the Trail Making Test was administered and the time taken to complete part B was used in the subsequent analysis. In the Digit Symbol Test, used as a measure of speed of information processing, the number of symbols matched correctly to their corresponding numbers in 90 seconds was recorded. The Hospital Anxiety and Depression Scale (HAD A and HAD D) was also used for the assessment of mood states, as these can affect performance on the tests, and the National Adult Reading Test (NART) was used to estimate Intelligence Quotient (IQ). |
| Secondary outcome measure(s) | 1. Total cardiovascular mortality 2. All cause mortality 3. Angina 4. Intermittent claudication 5. Transient ischaemic attack 6. Side effects/adverse events |
| Sources of funding | 1. British Heart Foundation (UK) (ref: RG/97006) 2. Chief Scientist Office (CSO) (UK) (ref: K/OPR/2/2/D320) Cognitive decline endpoint: The Wellcome Trust (UK) (grant ref: 057762) |
| Sponsor name | University of Edinburgh (UK) |
| Sponsor details | Old College South Bridge Edinburgh United Kingdom EH8 9YL |
| Sponsor website | http://www.ed.ac.uk/ |
| Contact name | Prof FGR Fowkes |
| Contact details | Wolfson Unit for Prevention of Peripheral Vascular Diseases University of Edinburgh Teviot Place Edinburgh United Kingdom EH8 9AG |
| Contact telephone | +44 (0)131 650 3219 |
| Contact fax | +44 (0)131 650 6909 |
| Contact email | Gerry.Fowkes@ed.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66587262 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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