STREAM Trial - Statins in Multimorbid Older Adults Without Cardiovascular Disease
NCT ID: NCT05178420
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1881 participants
INTERVENTIONAL
2021-11-16
2026-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Statin discontinuation
Discontinuation of statin therapy - statin therapy will be stopped from the next scheduled intake after study inclusion (intervention arm).
Statin discontinuation
Statin therapy will be stopped. Additional lipid-lowering medication lowering LDL cholesterol will also be stopped.
Statin continuation
Continuation of statin therapy - no change in the prescribed statin therapy (control arm).
No interventions assigned to this group
Interventions
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Statin discontinuation
Statin therapy will be stopped. Additional lipid-lowering medication lowering LDL cholesterol will also be stopped.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
Exclusion Criteria
* 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
* 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)
2. 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
3. Diagnosis of familial hypercholesterolemia based on Dutch lipid score ≥6 based on available documents (LDL cholesterol, family history, personal history)
4. 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)
5. Participation to a clinical trial with potential impact on the STREAM cardiovascular endpoints (based on clinical judgment)
70 Years
ALL
No
Sponsors
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University of Bern
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Nicolas Rodondi, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
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UNIVERSITY HOSPITAL CENTER of Bordeaux
Bordeaux, Nouvelle Acquitaine, France
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Klinik Barmelweid AG
Barmelweid, Canton of Aargau, Switzerland
Centre hospitalier Bienne
Biel/Bienne, Canton of Bern, Switzerland
Spital Limmattal
Schlieren, Canton of Zurich, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, Switzerland
Luzerner Höhenklinik Montana AG
Crans-Montana, Valais, Switzerland
Kantonsspital Aarau
Aarau, , Switzerland
Kantonsspital Baden
Baden, , Switzerland
Universitätsspital Basel
Basel, , Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, , Switzerland
Clinic for General Internal Medicine, Bern University Hospital Bern
Bern, , Switzerland
Hospital Burgdorf
Burgdorf, , Switzerland
HFR Fribourg
Fribourg, , Switzerland
Hôpital La Tour
Geneva, , Switzerland
Hôpitaux Universitaires de Genève (Geriatrics)
Geneva, , Switzerland
Hôpitaux Universitaires de Genève (Internal Medicine)
Geneva, , Switzerland
Hospital Langnau
Langnau, , Switzerland
CHUV Lausanne
Lausanne, , Switzerland
Hôpital Neuchâtelois
Neuchâtel, , Switzerland
Hospital St. Gallen (Geriatrics)
Sankt Gallen, , Switzerland
Kantonsspital Schaffhausen
Schaffhausen, , Switzerland
Stadspital Waid
Zurich, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STREAM
Identifier Type: -
Identifier Source: org_study_id
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