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New treatment option for Statin Treatment for Primary Prevention
Official title STREAM Trial - Subclinical Atherosclerosis
ClinicalTrials.gov ID: NCT05482399
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- ≥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...
- Taking a statin for ≥80% of the time during the year before baseline
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
- 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-c, 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 an online tool: https://cancersurvivalrates.com)
- Body measures exceeding the CT scanner limits (morbid obesity exceeding weight and diameter limits)
- Cardiac implants with metallic interference, such as pacemaker and mechanical heart valves
- Orthopedic hardware in the mid or lower thoracic spine
- Inability to hold breath for 10 seconds
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.