Evaluating the effects of continuing or stopping statins in older adults with multiple health conditions
Official title: Utility of Biomarkers With Statin Therapy in Multimorbid Older Adults - An Ancillary Study Nested Within a Randomized Trial
Run by Insel Gruppe AG, University Hospital Bern · NCT05482386 · Data updated 2026-11-12
This study is testing whether older adults with multiple health issues feel better and have fewer heart problems if they keep taking statins or stop taking them.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | November 21, 2022 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | November 30, 2023 |
| Trial ID | NCT05482386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 70 and older with at least two chronic conditions who have been taking statins consistently for the past year.
✕Probably not a fit
Patients with a history of cardiovascular disease or those who are not multimorbid may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the impact of statin discontinuation versus continuation in older adults aged 70 and above who are multimorbid and currently taking statins for primary prevention of cardiovascular disease. The study will enroll 500 participants and measure baseline cardiovascular biomarkers to assess the risk of cardiovascular events and all-cause mortality after stopping statins. The aim is to determine if those with elevated biomarker levels benefit from continuing statin therapy compared to those who do not. This randomized controlled trial seeks to provide clarity on the appropriateness of statin use in this specific population.
Why it matters
Potential benefit: If successful, this study could help identify which older adults with multimorbidity may safely discontinue statins, potentially reducing unnecessary medication use and associated side effects.
How similar studies have gone: While there have been studies on statin use in older adults, this specific approach focusing on multimorbidity and biomarker levels is novel and has not been rigorously tested in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥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 * Taking a statin for ≥80% of the time during the year before baseline Exclusion criteria: 1. Secondary prevention based on previous large statin trials, defined as: * History of myocardial infarction type 12 (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 ischemic stroke OR * History of Transient Ischemic Attack, defined as transient neurological deficit without diffusion restriction in MRI OR * History of carotid revascularization (stent or bypass) OR * History of peripheral arterial disease requiring revascularization (stent or 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-c, 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 an online tool: https://cancersurvivalrates.com)
Where it's running
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University Hospital of Bern, University of Bern
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Manuel R Blum, MD, MSc — University Hospital of Bern, University of Bern, Switzerland; Institute of Primary Health Care, University of Bern, Switzerland
- Study coordinator: Manuel R Blum, MD, MSc
- Email: manuel.blum@insel.ch
- Phone: +41 31 632 21 11
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the effects of statin continuation versus discontinuation in older adults with subclinical atherosclerosis
This study is testing whether older adults with early signs of heart disease do better if they keep taking their statin medication or if they stop it.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.