AspiriN To Inhibit SEPSIS (ANTISEPSIS) trial

Phase 4

Completed

• Conditions: sepsis; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12613000349741
• Lead Sponsor: ational Health and Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17000

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality due to sepsis[Intention to treat; on treatment/placebo. The primary outcome will be measured at the end of the study as multiple events may be recorded in study participants.]

Secondary Outcome Measures

Name	Time	Method
admission to ICU for sepsis[Intention to treat; on treatment/placebo. The secondary outcomes will be measured at the end of the study as multiple events may be recorded in study participants.];admission to hospital for sepsis[Intention to treat; on treatment/placebo. The secondary outcomes will be measured at the end of the study as multiple events may be recorded in study participants.]