Actively Recruiting
STREAM Trial - Subclinical Atherosclerosis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-11-30
500
Participants Needed
1
Research Sites
227 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. To better target adults who may benefit from statins in primary prevention, coronary artery calcium (CAC) measurement is rapidly increasing in clinical use and is recommended for risk re-classification in some guidelines. Older patients with a high burden of subclinical atherosclerosis 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 CAC to determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with evidence of subclinical atherosclerosis at baseline as measured by CAC.
CONDITIONS
Official Title
STREAM Trial - Subclinical Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 70 years of age or older
- Having two or more chronic health conditions lasting at least six months besides dyslipidemia treated by statins
- Taking a statin for at least 80% of the time during the year before starting the study
You will not qualify if you...
- History of heart attack, unstable angina, or stable angina with significant coronary disease
- Previous coronary procedures like stent placement or bypass surgery
- History of ischemic stroke or transient ischemic attack
- History of carotid or peripheral arterial revascularization
- Aortic disease needing repair or aortic aneurysm larger than 5.5 cm in men or 5.2 cm in women
- Familial hypercholesterolemia with a Dutch lipid score of 6 or more
- Expected risk of death within 3 months due to palliative care status or advanced metastatic cancer
- Body size exceeding CT scanner limits due to morbid obesity
- Cardiac implants causing metal interference such as pacemakers or mechanical heart valves
- Orthopedic hardware in the mid or lower thoracic spine
- Inability to hold breath for 10 seconds
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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