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Statin Treatment for Primary PreventionSTREAMNCT05178420

STREAM Trial - Statins in Multimorbid Older Adults Without Cardiovascular Disease

A study testing Statin discontinuation in people with Statin Treatment for Primary Prevention, run by Insel Gruppe AG, University Hospital Bern at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Statin Treatment for Primary Prevention
What is being tested?
Statin discontinuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,880 participants
Where
24 sitesin 3 countries
Study dates
16 Nov 2021to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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 enrollment

Who cannot join

  • 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 (does not apply to clearly cardio-embolic causes for stroke e.g. due to atrial fibrillation), OR
Show all 16Show fewer
  • History of Transient Ischemic Attack, defined as transient neurological deficit without diffusion restriction in MRI, OR
  • History of carotid revascularization (stent, bypass, CEA (carotid thrombendartectomy)), OR
  • History of peripheral arterial disease requiring revascularization (e.g. PTA (percutaneous transluminal angioplasty), stent, femoral TEA (thrombendartectomy), 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)
  • Participation to a clinical trial with potential impact on the STREAM cardiovascular endpoints (based on clinical judgment)

Trial locations and contacts

24 sites in 3 countries.

24 sites in 3 countries

Switzerland22 sites

  • Kantonsspital Aarau

    Aarau

  • Kantonsspital Baden

    Baden

  • Klinik Barmelweid AG

    Barmelweid, Canton of Aargau, 5017

  • Universitätsspital Basel

    Basel

  • Ospedale Regionale di Bellinzona e Valli

    Bellinzona

  • Clinic for General Internal Medicine, Bern University Hospital Bern

    Bern, 3010

  • Centre hospitalier Bienne

    Biel/Bienne, Canton of Bern, 2501

  • Hospital Burgdorf

    Burgdorf

  • Kantonsspital Graubünden

    Chur, Kanton Graubünden, 7000

  • Luzerner Höhenklinik Montana AG

    Crans-Montana, Valais, 3963

  • HFR Fribourg

    Fribourg, 1752

  • Hôpital La Tour

    Geneva

  • Hôpitaux Universitaires de Genève (Geriatrics)

    Geneva

  • Hôpitaux Universitaires de Genève (Internal Medicine)

    Geneva

  • Hospital Langnau

    Langnau

  • CHUV Lausanne

    Lausanne

  • Hôpital Neuchâtelois

    Neuchâtel

  • Hospital St. Gallen (Geriatrics)

    Sankt Gallen

  • Kantonsspital Schaffhausen

    Schaffhausen, 8208

  • Spital Limmattal

    Schlieren, Canton of Zurich, 8952

  • Stadspital Waid

    Zurich

  • Stadtspital Triemli

    Zurich

Other trials in Switzerland

France1 site

  • UNIVERSITY HOSPITAL CENTER of Bordeaux

    Bordeaux, Nouvelle Acquitaine, 33404 Talence Cedex

Other trials in France

Netherlands1 site

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333

Other trials in Netherlands

About this study

Official title: Discontinuing Statins in Multimorbid Older Adults Without Cardiovascular Disease (STREAM) - a Randomized Non-inferiority Clinical Trial

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.

Read the detailed 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, France and the Netherlands. 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.

Being tested
Statin discontinuation
Keywords
Multimorbidity, Primary prevention, Older adults, Deprescribing, Statin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Statin discontinuationOther

    Also called Intervention arm

    Statin therapy will be stopped. Additional lipid-lowering medication lowering LDL cholesterol will also be stopped.

Study groups in NCT05178420
Study groupRoleWhat they receive
Statin discontinuationExperimentalDiscontinuation of statin therapy - statin therapy will be stopped from the next scheduled intake after study inclusion (intervention arm).
Receives: Other: Statin discontinuation
Statin continuationNo interventionContinuation of statin therapy - no change in the prescribed statin therapy (control arm).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoint of all-cause death and major non-fatal CV events (non-fatal myocardial infarction, non-fatal ischemic stroke)

    The primary endpoint is a composite endpoint of all-cause death and major non-fatal CV events (non-fatal myocardial infarction, non-fatal ischemic stroke). All-cause death (and not CV death only) is chosen to account for a possible shift from CV to other causes of death. The composite endpoint was selected to assess the net clinical benefit in this population with expected high mortality. The clinical event committee which classifies suspected events for the primary and secondary clinical outcomes is blinded. The primary analysis timeframe is at 24 months, and data collection is performed up to 48 months.

    Measured: 24 months

Secondary outcomes (11)

  1. Composite endpoint of all-cause death and major non-fatal CV events (non-fatal myocardial infarction, non-fatal ischemic stroke)

    Composite endpoint of all-cause death and major non-fatal CV events (non-fatal myocardial infarction, non-fatal ischemic stroke).

    Measured: up to 48 months

  2. All-cause death

    All deaths (for any reason)

    Measured: up to 48 months

  3. Non-CV death

    All deaths except of deaths due to major CV events

    Measured: up to 48 months

  4. Major CV events

    CV death, non-fatal myocardial infarction and non-fatal ischemic stroke

    Measured: up to 48 months

  5. Total CV events

    CV death, non-fatal myocardial infarction, hospitalization for unstable angina, non-fatal ischemic stroke (including TIA) and arterial revascularization (coronary and peripheral urgent and non-urgent revascularization)

    Measured: up to 48 months

  6. Total composite events

    All-cause death, non-fatal myocardial infarction, hospitalization for unstable angina, non-fatal ischemic stroke (including TIA) and arterial revascularization (coronary and peripheral urgent and non-urgent revascularization)

    Measured: up to 48 months

  7. EQ-5D questionnaire

    EQ-5D is the name of the instrument and not an acronym. General quality of life assessment. The possible range of scores goes from 0 to 1.0, with higher scores indicating better quality of life.

    Measured: 3, 12 (primary analysis), 24, 36, 48 months

  8. Verbal numeric pain rating score (VNPRS)

    To assess statin associated muscle symptoms. The VNPRS is scored from 0-100, with higher scores indicating higher degree of pain.

    Measured: 3 months

  9. Self-reported falls

    Self-reported falls, each participant will collect and list all falls during the first 12 months after randomization. Circumstances and medical consequences of each fall will be collected. Aggregated as rate of falls (falls per person per year).

    Measured: 12 months

  10. Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F questionnaire)

    5-item questionnaire, the score ranges from 0 to 10 with higher scores indicating higher degree of sarcopenia.

    Measured: 12 (primary analysis), 24, 36, 48 months

  11. Girerd medication adherence scale

    6-item questionnaire, the score ranges from 0 to 6, higher scores indicating worse medication adherence.

    Measured: 12 (primary analysis), 24, 36, 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start16 Nov 2021
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study subjects are randomly assigned in a 1:1 ratio to either discontinue (intervention arm) or continue (control arm) statin therapy
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178420
Sponsor's protocol ID
STREAM
Acronym
STREAM
Status last verified
May 2026
First submitted
15 Nov 2021
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be deposited in the BORIS Research Data, the research data repository of the University of Bern. BORIS Research Data allows searching and is indexed by search engines. All items are stored with a unique Digital Object Identifier (DOI) that can be referenced in respective publication. It should be noted that the investigators plan to register and deposit data that relates to individual, primary publications and not the whole study database as such, as the investigators will use them for secondary analysis. This enables other researchers to replicate published analyses and results as well as to re-use the data for additional analyses such as metaanalysis. It is planned to disseminate the results of the trial to key target groups using the Lavis' framework for research knowledge transfer

Publications

  • Byrne P, Cullinan J, Smith SM. Statins for primary prevention of cardiovascular disease. BMJ. 2019 Oct 16;367:l5674. doi: 10.1136/bmj.l5674. No abstract available.

    PubMed 31619406

  • Shepherd J, Blauw GJ, Murphy MB, Bollen EL, Buckley BM, Cobbe SM, Ford I, Gaw A, Hyland M, Jukema JW, Kamper AM, Macfarlane PW, Meinders AE, Norrie J, Packard CJ, Perry IJ, Stott DJ, Sweeney BJ, Twomey C, Westendorp RG; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002 Nov 23;360(9346):1623-30. doi: 10.1016/s0140-6736(02)11600-x.

    PubMed 12457784

  • Han BH, Sutin D, Williamson JD, Davis BR, Piller LB, Pervin H, Pressel SL, Blaum CS; ALLHAT Collaborative Research Group. Effect of Statin Treatment vs Usual Care on Primary Cardiovascular Prevention Among Older Adults: The ALLHAT-LLT Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):955-965. doi: 10.1001/jamainternmed.2017.1442.

    PubMed 28531241

  • Cholesterol Treatment Trialists' Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Lancet. 2019 Feb 2;393(10170):407-415. doi: 10.1016/S0140-6736(18)31942-1.

    PubMed 30712900

  • Ruscica M, Macchi C, Pavanello C, Corsini A, Sahebkar A, Sirtori CR. Appropriateness of statin prescription in the elderly. Eur J Intern Med. 2018 Apr;50:33-40. doi: 10.1016/j.ejim.2017.12.011. Epub 2018 Jan 5.

    PubMed 29310996

  • van der Ploeg MA, Streit S, Achterberg WP, Beers E, Bohnen AM, Burman RA, Collins C, Franco FG, Gerasimovska-Kitanovska B, Gintere S, Gomez Bravo R, Hoffmann K, Iftode C, Pestic SK, Koskela TH, Kurpas D, Maisonneuve H, Mallen CD, Merlo C, Mueller Y, Muth C, Petrazzuoli F, Rodondi N, Rosemann T, Sattler M, Schermer T, Ster MP, Svadlenkova Z, Tatsioni A, Thulesius H, Tkachenko V, Torzsa P, Tsopra R, Tuz C, Vaes B, Viegas RPA, Vinker S, Wallis KA, Zeller A, Gussekloo J, Poortvliet RKE. Patient Characteristics and General Practitioners' Advice to Stop Statins in Oldest-Old Patients: a Survey Study Across 30 Countries. J Gen Intern Med. 2019 Sep;34(9):1751-1757. doi: 10.1007/s11606-018-4795-x. Epub 2019 Jan 16.

    PubMed 30652277

  • Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.

    PubMed 25798575

  • Aebi PS, Adam L, Haller M, Bardoczi JB, Gencer B, Bonnet F, Beer JH, Carballo S, Christ-Crain M, Feller M, Gabutti L, Haynes AG, Moutzouri E, Chocano-Bedoya PO, Bassetti S, Escher R, Egger M, Poortvliet RKE, Schuetz P, Trelle S, Wertli MM, Zekry D, Mean M, Aujesky D, Bauer D, Blum MR, Rodondi N. Rationale and design of 'discontinuing statins in multimorbid older adults without cardiovascular disease (STREAM)': study protocol of a randomised non-inferiority clinical trial. BMJ Open. 2025 May 23;15(5):e093833. doi: 10.1136/bmjopen-2024-093833.

    PubMed 40409969

Questions about this trial

What is this clinical trial studying?

A study testing Statin discontinuation in people with Statin Treatment for Primary Prevention, run by Insel Gruppe AG, University Hospital Bern at 24 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Switzerland, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint of all-cause death and major non-fatal CV events (non-fatal myocardial infarction, non-fatal ischemic stroke) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178420, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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