Tackling heart disease: the Scottish aspirin trial

Randomised controlled trial of low dose Aspirin in the prevention of cardiovascular events and death in subjects with Asymptomatic Atherosclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66587262

Enrollment

3350

Registered

2002-01-31

Start date

1998-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease, cognitive decline Circulatory System Cardiovascular disease

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 cor

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 M

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Receiving aspirin and/or other anticoagulants 2. Contraindication to aspirin therapy

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
1. Total cardiovascular mortality 2. All cause mortality 3. Angina 4. Intermittent claudication 5. Transient ischaemic attack 6. Side effects/adverse events	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026