None listed
Conditions
Brief summary
The ANTISEPSIS study will investigate whether the low doses of aspirin being trialled in the randomised controlled ASPREE study work to reduce the severity of infection in the patients who have been taking aspirin. There are numerous pieces of information from test tube and laboratory animal studies that show us that low dose aspirin helps to reduce inflammation which contributes to the disease caused by severe infection. If we can show that low dose aspirin safely reduces the severity of infection in elderly patients we will be able to recommend that it should be taken in all patients who are not at high risk of side effects of this drug. We hypothesise that severe outcomes relating to sepsis in the elderly may be prevented by daily low-dose aspirin. We have the opportunity to test this hypothesis through a substudy of the ASPirin in Preventing Events in the Elderly (ASPREE) trial. ASPREE is a major, Australian/US randomised controlled primary prevention trial of low dose aspirin in the elderly. Our aims are to use the ASPREE randomised controlled trial (RCT) framework and extend data collection relating to sepsis events in its participants to assess our primary endpoint: reduction of deaths contributed to by sepsis in participants receiving aspirin versus placebo. We will also conduct an analysis of two secondary endpoints: reduction of severe infection episodes requiring hospital admissions reduction of ICU admissions among patients hospitalised for severe sepsis The ASPREE study, which will provide a sufficient sample size to assess our primary outcome, represents an ideal chance to assess the impact of aspirin on outcomes of sepsis in the trial population of elderly participants.
Interventions
Aspirin 100mg taken orally once daily. The study drugs, aspirin or placebo, will be taken for a minimum of 5 years and maximum of 7 years according to the timing of entry to study in the enrollment period.
One “Study Drug Accountability” Log will be provided for each study participant. These Drug Accountability Logs record the drug dispensed to the participant and drug returned from the participant.
The Study Drug Accountability log will record, at minimum, the following information:
Date disp
Aspirin 100mg taken orally once daily. The study drugs, aspirin or placebo, will be taken for a minimum of 5 years and maximum of 7 years according to the timing of entry to study in the enrollment period. One “Study Drug Accountability” Log will be provided for each study participant. These Drug Accountability Logs record the drug dispensed to the participant and drug returned from the participant. The Study Drug Accountability log will record, at minimum, the following information: Date dispensed (initials of dispenser) Date of medication return (initialed by research staff) Number of tablets returned Date of medication destruction
Sponsors
National Health and Medical Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
AS PER ASPREE STUDY Non-institutionalised Willing and able to provide informed consent, and willing to accept the study requirements Physically capable of regularly attending his/her family physician. Without major cardiovascular disease, dementia or other exclusion criteria, as listed below.
Exclusion criteria
AS PER ASPREE STUDY A history of a diagnosed cardiovascular event defined as MI, heart failure, peripheral arterial disease, angina pectoris, stroke, transient ischemic attack, >50% carotid stenosis or previous carotid endarterectomy or stenting, coronary artery angioplasty or stenting, coronary artery bypass grafting, or abdominal aortic aneurysm. A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer or obstructive airways disease. A current or recurrent condition with a high risk of major bleeding, e.g. cerebral aneurysm or cerebral AV malformation, any bleeding diathesis, gastrointestinal malignancy, recent peptic ulcer, liver disease, oesophageal varicosities, uremia, aortic aneurysm or any other condition known to be associated with a high risk of serious bleeding. Anaemia, i.e. haemoglobin level below the normal value for the gender of the participant (males: 13g/L, females: 11.5 g/L). Absolute contraindication or allergy to aspirin. Current participation in a clinical trial. Current continuous use of aspirin or other anti-platelet drug or anticoagulant. Participants with previous use may enter the trial, provided they have been off the medication for 3 months. (Concurrent use of a NSAID is not an exclusion criterion but subjects are requested to take their trial medication 30 minutes prior to other medications.) A systolic blood pressure 180 mmHg and or a diastolic blood pressure 105mmHg A history of a clinical diagnosis of diabetes (glucose 7.0 mmol/L (fasting) or 11.1 mmol/L (non fasting) ) A history of dementia or a Modified Mini-Mental State Examination (3MS) score 77 as measured at Visit 1: Lifestyle Profile and Screening. An inability to perform independently, or more than ‘A little difficulty’ reported in performing, any one of the 6 Katz ADLs. Pill-taking compliance outside the range of 80-120% during the placebo run-in phase.
Outcome results
None listed