STREAM Trial - Statins in Multimorbid Older Adults Without Cardiovascular Disease
About the study
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. The aim of this randomized controlled trial (RCT) is to provide guidance on the benefits and risks of statin deprescribing in multimorbid older adults.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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 enrolment
- Participation to a clinical trial with potential impact on the STREAM cardiovascular endpoints
EXCLUSION CRITERIA
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, 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)
- 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
- Diagnosis of familial hypercholesterolemia based on Dutch lipid score ≥6 based on available documents (LDL cholesterol, family history, personal history)
- 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)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Statin Treatment for Primary Prevention
Age
70+
Phase
NA
Participants Needed
1800
Est. Completion Date
Nov 15, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Insel Gruppe AG, University Hospital Bern
ClinicalTrials.gov NCT Identifier
NCT05178420
Study Number
STREAM
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?