Actively Recruiting
STREAM Trial - Biomarker
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-11-30
500
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STREAM Trial - Biomarker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 70 years of age or older
- Have two or more chronic health conditions lasting at least 6 months, besides high cholesterol treated by statins
- Taking a statin medication at least 80% of the time during the year before starting the study
You will not qualify if you...
- History of heart attack, unstable or stable angina with significant coronary disease, stroke, transient ischemic attack, carotid or peripheral arterial revascularization
- Aortic disease requiring vascular repair or large aortic aneurysm (men >5.5 cm, women >5.2 cm)
- Diagnosis of familial hypercholesterolemia (Dutch lipid score ≥6)
- Expected risk of death within 3 months due to advanced illness, including palliative care patients or advanced metastatic cancer with poor prognosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital of Bern, University of Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
M
Manuel R Blum, MD, MSc
CONTACT
N
Nicolas Rodondi, MD, MAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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