STREAM Trial - Biomarker

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 28, 2022

Keywords

ClinConnect Summary

The STREAM Trial is a research study that is exploring whether older adults aged 70 and above, who have multiple health issues and are currently taking statins (medications used to lower cholesterol), should continue their statin treatment for preventing heart problems. The study aims to find out if stopping statins could lead to an increased risk of heart events or death in these patients, especially for those with certain blood test results that indicate higher heart risk. The researchers are looking for about 500 participants who meet specific criteria, including being 70 years or older, having at least two other chronic health conditions, and having been on statins for most of the past year.

If you or a loved one is eligible and decides to participate, you will be randomly assigned to either continue taking statins or stop taking them. Throughout the trial, the researchers will monitor your health to see how stopping the medication affects your risk of heart events and overall health. This study is important because it could help determine the best treatment approach for older adults with multiple health conditions who are currently taking statins for heart disease prevention.

Gender

ALL

Eligibility criteria

• 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
• • Taking a statin for ≥80% of the time during the year before baseline
• Exclusion criteria:
• 1. Secondary prevention based on previous large statin trials, defined as:
• • History of myocardial infarction type 12 (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 ischemic 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)
• • 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-c, 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 an online tool: https://cancersurvivalrates.com)