Evaluating the effects of statin continuation versus discontinuation in older adults with subclinical atherosclerosis
Utility of Coronary Artery Calcification With Statin Therapy in Multimorbid Older Adults - An Ancillary Study Nested Within a Randomized Trial
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05482399 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of continuing or discontinuing statin treatment in older adults aged 70 and above who have multiple chronic conditions and are currently taking statins for primary prevention of cardiovascular disease. The study will measure coronary artery calcium (CAC) levels to identify patients with subclinical atherosclerosis and assess whether statin discontinuation affects the risk of cardiovascular events and all-cause mortality. A total of 500 participants will be randomized to either continue or stop their statin therapy, providing valuable insights into the management of statin therapy in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 70 and older with multiple chronic conditions who have been taking statins for primary prevention.
Not a fit: Patients with a history of cardiovascular disease or those not meeting the multimorbidity criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which older adults may safely discontinue statins, potentially reducing unnecessary medication use and associated side effects.
How similar studies have performed: While the use of CAC measurement for risk stratification is gaining traction, this specific approach to evaluating statin therapy in multimorbid older adults is relatively novel and has not been rigorously tested in previous studies.
Eligibility criteria
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) 5. Body measures exceeding the CT scanner limits (morbid obesity exceeding weight and diameter limits) 6. Cardiac implants with metallic interference, such as pacemaker and mechanical heart valves 7. Orthopedic hardware in the mid or lower thoracic spine 8. Inability to hold breath for 10 seconds
Where this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.