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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03796156
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18 years and over at the date of screening
* .Subjects with CKD (reduced eGFR and/or albuminuria) defined as: • estimated glomerular filtration rate \[eGFR\] \<60mL/min/1.73m2 for at least 90 days, and/or • kidney disease code on the GP electronic patient AND most recent eGFR in CKD-defining range (\<60mL/min/1.73m2), and/or • albuminuria or proteinuria (defined as urine albumin:creatinine ratio \[ACR\] ≥3mg/mmol, and/or urine protein:creatinine ratio \[PCR\] ≥15mg/mmol, and/or +protein or greater on reagent strip)
* Subjects who are willing to give permission for their paper and electronic medical records to be accessed by trial investigators
* Subjects who are willing to be contacted and interviewed by trial investigators
* Subjects who can communicate well with the investigator or designee, understand the requirements of the study and understand and sign the written informed consent
Exclusion Criteria
* Subjects with CKD GFR category 5
* Subjects with pre-existing cardiovascular disease (angina, myocardial infarction, stroke, transient ischaemic attack (TIA), significant peripheral vascular disease, coronary or peripheral revascularisation for atherosclerotic disease)
* Subjects with a current pre-existing condition associated with increased risk of bleeding other than CKD
* Subjects currently prescribed anticoagulants or antiplatelet agent, or taking over the counter (OTC) aspirin continuously
* Subjects who are currently and regularly taking other drugs with a potentially serious interaction with aspirin
* Subjects with a known allergy to aspirin or definite previous clinically important adverse reaction
* Subjects with poorly controlled hypertension (systolic blood pressure \[BP\] ≥180 mmHg and/or diastolic BP ≥105 mmHg)
* . Subjects with other conditions which in the opinion of their General Practitioner (GP) would preclude prescription of aspirin in routine clinical practice, for example significant anaemia or thrombocytopenia
* Subjects who are pregnant or likely to become pregnant during the study period
* Subjects with malignancy that is life-threatening or likely to limit prognosis, other life-threatening co-morbidity, or terminal illness
* Subjects whose behaviour or lifestyle would render them less likely to comply with study medication
* Subjects in prison
* Subjects currently participating in another clinical trial of an investigational medicinal product or who have taken part in such a trial in the last three months (Covid-19 vaccine studies are acceptable)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03796156
Study Brief:
Protocol Section:
NCT03796156