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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT05178420
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* ≥70 years of age
* Multimorbid with ≥2 coexistent chronic conditions (defined by ICD-10 codes) with an estimated duration of 6 months or more based on clinical decision, besides dyslipidemia treated by statins
* Intake of a statin for ≥80% of the time during the year before enrollment
Exclusion Criteria:
1. Cardiovascular secondary prevention setting based on previous large statin trials, defined as:
* History of myocardial infarction type 1 (NSTEMI/STEMI), OR
* History of unstable angina, defined as ACS symptomatic at rest, crescendo or new-onset angina (CCS 2 or 3) without ECG or cardiac biomarker changes (based on available documents), OR
* Stable angina pectoris with a documented ischemia on a stress test or with a significant coronary disease defined as a coronary stenosis \>50%, OR
* History of percutaneous coronary intervention (balloon or stent) or coronary artery bypass graft, OR
* History of Stroke (does not apply to clearly cardio-embolic causes for stroke e.g. due to atrial fibrillation), OR
* History of Transient Ischemic Attack, defined as transient neurological deficit without diffusion restriction in MRI, OR
* History of carotid revascularization (stent, bypass, CEA (carotid thrombendartectomy)), OR
* History of peripheral arterial disease requiring revascularization (e.g. PTA (percutaneous transluminal angioplasty), stent, femoral TEA (thrombendartectomy), bypass; Fontaine IV)
2. Aortic disease that required a vascular repair or aortic aneurysm with a maximum diameter \>5.5 cm (men) or \>5.2 cm (women) based on available documents
3. Diagnosis of familial hypercholesterolemia based on Dutch lipid score ≥6 based on available documents (LDL cholesterol, family history, personal history)
4. Elevated risk of death within 3 months after baseline, defined as:
* Hospitalized patients planned for palliative care within 24h of admission OR
* Hospitalized patients with a Palliative Performance Scale (PPS) level \<30% (based on situation at least 1 month before hospitalization), this corresponds to an estimated survival of 43% after 3 months; OR
* Patients with an advanced metastatic cancer prognosis of ≤20% survival rate within 1 year after baseline (based on: https://cancersurvivalrates.com)
5. Participation to a clinical trial with potential impact on the STREAM cardiovascular endpoints (based on clinical judgment)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT05178420
Study Brief:
Protocol Section:
NCT05178420