Aspirin for the prevention of cognitive decline in the Elderly: a Neuro-Vascular Imaging Study (ENVIS-ion), a sub-study of ASPirin in Reducing Events in the Elderly (ASPREE)

A multi-centre, randomised, double-blind, placebo controlled trial of the effects of 100mg enteric-coated aspirin on rate of increase of magnetic resonance imaging(MRI)-based white matter hyperintensity (WMH) and silent brain infarction (SBI).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000613202

Acronym

ENVIS-ion

Enrollment

600

Registered

2009-07-22

Start date

2010-04-27

Completion date

2012-04-03

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The ENVIS-ion trial will examine whether low dose aspirin is effective in delaying the onset of declining abilities of thinking and memory in healthy older adults. Participants in the ENVIS-ion trial will be recruited from men and women who have agreed and consented to participate in the clinical trial of low dose aspirin (the ASPREE Trial ISRCTN83772183). The main features of the ENVIS-ion trial are additional measurement of brain and retinal structures by magnetic resonance imaging (MRI) and retinal photography in each participant before starting on the study drug and after treatment with aspirin or placebo for 3 years. As a part of the ASPREE study, mental functions are assessed every year by questionnaires administered by a trained researcher. For ENVIS-ion, participants will have extra questionnaires to further test their mental abilities. MRI of brain structure will detect markers of early worsening of thinking and memory abilities. Blood vessels of the retina share many features with vessels of the brain. We will compare whether aspirin lessens changes over time of features shown with brain MRI and retinal photography and compare these with the questionnaire measurements of mental function.

Interventions

Acetylsalicylic acid (aspirin) 100 mg; enteric coated unscored white tablet taken once per day for an average of 3 years

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

70 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All subjects will be aged 70 years or more and capable of attending their usual family physician's clinic, providing informed consent and have no known contraindications to MRI.

Exclusion criteria

1. A history of cardiovascular morbidity defined as myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, greater than 50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, or coronary artery bypass grafting 2. A serious intercurrent illness likely to cause death within the next 5 years 3. A current or recurrent condition with a high risk of major bleeding e.g. cerebral aneurysm or cerebral arteriovenous (AV) malformation, any bleeding diathesis, gastrointestinal malignancy, peptic ulcer, liver disease, uraemia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding 4. Absolute contraindication or allergy to aspirin 5. Current participation in a clinical trial 6. Current continuous use of aspirin or other anti-platelet drug or anticoagulant 7. A history of dementia 8. In addition those who lie outside of tolerance levels of 8-104% during placebo run-in phase will not be randomised 9. An inability to perform independently one of the 6 Katz Activities of Daily Living (walking, bathing, dressing, transferring from chair or bed, toileting, eating) 10. Pill taking compliance below 80% on tablet count during a placebo run-in phase 11. Absolute contraindications to undergo MRI

Outcome results