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RECRUITING

NCT05482386

STREAM Trial - Biomarker

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: Utility of Biomarkers With Statin Therapy in Multimorbid Older Adults - An Ancillary Study Nested Within a Randomized Trial

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2022-11-21

Completion Date

2026-11

Last Updated

2023-11-30

Healthy Volunteers

Conditions

Statin Treatment for Primary Prevention

Interventions

OTHER

Statin discontinuation

Statin therapy will be stopped. Additional lipid-lowering medication lowering LDL cholesterol will also be stopped.

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)

Locations (1)

University Hospital of Bern, University of Bern

Bern, Switzerland