| NCT ID | NCT05482386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Statin Treatment for Primary Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-11-21 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-11-21 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Statins are among the most widely used drugs. While they were found to be effective for primary and secondary prevention of cardiovascular disease (CVD) in middle-aged subjects, their benefits for primary prevention in older adults (aged ≥70 years) without CVD are uncertain, particularly for those with multimorbidity. Older patients with elevated biomarkers associated with cardiovascular (CV) risk might benefit from continuing statins to prevent CV outcomes, but this hypothesis has not been rigorously tested in randomized clinical trials (RCTs). To address these questions, the investigators conduct a RCT in 500 multimorbid adults ≥70 years old taking statins for primary prevention who will be randomized to statin continuation vs. statin discontinuation, and measure baseline biomarkers to determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with baseline levels of previously validated blood biomarkers associated with increased risk of CV outcomes.
Eligibility 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)
Contact & Investigator
Manuel R Blum, MD, MSc
PRINCIPAL INVESTIGATOR
University Hospital of Bern, University of Bern, Switzerland; Institute of Primary Health Care, University of Bern, Switzerland
Frequently Asked Questions
Who can join the NCT05482386 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Statin Treatment for Primary Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05482386 currently recruiting?
Yes, NCT05482386 is actively recruiting participants. Contact the research team at manuel.blum@insel.ch for enrollment information.
Where is the NCT05482386 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05482386 clinical trial?
NCT05482386 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Manuel R Blum, MD, MSc at University Hospital of Bern, University of Bern, Switzerland; Institute of Primary Health Care, University of Bern, Switzerland. The trial plans to enroll 500 participants.