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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT01330602
Eligibility Criteria:
Inclusion Criteria:
* Have a first-degree relative (i.e. a mother, father, brother or sister) with premature (onset \<65 years of age) atherosclerosis. This includes coronary artery disease/acute myocardial infarction, non-haemorrhagic stroke and peripheral vascular disease.
* Are classified as "intermediate risk" of experiencing a cardiovascular event in the next 5 years as determined via the Framingham Risk Equation 7, 22
* Live within a geographically accessible area for follow-up (i.e. within a 40km radius of the study centre)
* Are living independently in the community or their own home
* Are able and willing to provide written informed consent to participate in the study (this includes the ability to understand and speak English fluently and that the patient is mentally competent)
Exclusion Criteria:
* Pre-existing atherosclerotic disease
* Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* Have contraindications to the use of statin medications (includes pregnancy and breastfeeding)
* Unable to provide written informed consent to participate in this study
* Have a terminal malignancy requiring palliative care, or limited life expectancy or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
* Participating in another clinical research trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01330602
Study Brief:
Protocol Section:
NCT01330602