Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02970604
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be male or female outpatients.
* Age must be greater than 18 years.
* Subjects must be able and willing to give written informed consent, and to comply with the requirements of this study protocol.
* Subjects must be at intermediate to high cardiovascular risk as determined by a calculated 5 year CVD risk of 5% or greater (calculated using the 1991 Anderson Framingham risk equation with adjustments as defined by the New Zealand Guidelines Group recommendations)
Exclusion Criteria:
* Age less than 18 years.
* Previous MI, stroke, transient ischaemic attack (TIA) or known CAD.
* Subjects who have any other significant disease or disorder (including concurrent malignancy) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
* Known history of, or documented positive hepatitis B or C or HIV infection
* AST or ALT ≥ 3 x ULN.
* Creatinine clearance (CrCl) \< 60 mL/min measured by 24-hour urine collection or estimated by the Cockcroft and Gault formula.
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study, or with childbearing potential without using a medically accepted method of contraception (see notes 1-5 below)
* Patients already taking aspirin.
* Patients already taking anti-platelet agents (clopidogrel, ticagrelor etc), non-steroidal anti inflammatory drugs (NSAIDs), or anticoagulants (heparin, warfarin, dabigatran, etc).
* Patients who have a known intolerance to aspirin.
* Patients who have a contra-indication to aspirin as detailed below:
* Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) and to any of the excipients.
* Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
* Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia.
* Patients who are suffering from gout.
* Severe hepatic impairment.
* Severe renal impairment.
* Patients taking methotrexate used at doses \>15mg/week.
* History of peptic ulcer disease or upper gastrointestinal bleeding.
* Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Participants unlikely to comply well with study treatments or with the scheduled visits.
* Scheduled for procedures requiring general anaesthesia during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02970604
Study Brief:
Protocol Section:
NCT02970604