STREAM Trial - Statins in Multimorbid Older Adults Without Cardiovascular Disease (STREAM)

  • STATUS
    Recruiting
  • End date
    Nov 15, 2026
  • participants needed
    1800
  • sponsor
    University Hospital Inselspital, Berne
Updated on 24 March 2022

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. The aim of this randomized controlled trial (RCT) is to provide guidance on the benefits and risks of statin deprescribing in multimorbid older adults.

Description

Background

Until now, no RCT examining the benefits of statins in primary prevention has exclusively recruited multimorbid participants aged 70 years and older (70+), and 70+ participants are under-represented in most RCTs, including those examining statin benefits for primary prevention. However, statin side effects and drug interactions are common in populations of multimorbid older adults and might negatively impact quality of life. The proportion of patients developing myalgia on statins has been shown to be as high as 5-20% in observational studies; older age and polypharmacy are known risk factors for developing muscle problems under statins. Furthermore, multimorbid older adults with polypharmacy are more likely to experience side effects with statins (e.g. elevated liver enzymes, diabetes, myopathy, rhabdomyolysis) and drug-drug interactions (e.g. antibiotics, antifungals), with the potential consequences of drug toxicity, reduced physical activity, sarcopenia and falls. In practice, statins are often discontinued in multimorbid older adults without CVD after side effects. The net clinical benefit of statins for primary prevention in multimorbid 70+ older adults remains unclear, and the effect of multimorbidity might shift the evidence towards favoring no statin treatment, but no large RCT examined this issue.

Design

The study is a multicenter, randomized, non-inferiority trial conducted in multiple centers in Switzerland. Study subjects are randomly assigned in a 1:1 ratio to either discontinue (intervention arm) or continue (control arm) statin therapy. The study is open-label, with blinded outcome adjudication. After inclusion the study participants will be followed with phone calls, first after 3 months and then yearly for a mean of 24 months (min. follow-up period 12 months, max. follow-up period 48 months). Outcomes are assessed at each study follow-up.

Details
Condition Statin Treatment for Primary Prevention
Treatment Statin discontinuation
Clinical Study IdentifierNCT05178420
SponsorUniversity Hospital Inselspital, Berne
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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 newonset 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>)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note