Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT05482399

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

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University Hospital of Bern, University of Bern

Bern, Switzerland, 3010

Actively Recruiting

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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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