Discontinuing Statins in Multimorbid Older Adults without Cardiovascular Disease (STREAM) - a randomized non-inferiority clinical trial
Recruiting
- Conditions
- Cardiovascular disease1001108210003216
- Registration Number
- NL-OMON53293
- Lead Sponsor
- niversity Hospital Bern (Inselspital)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
• >=70 years of age
• Multimorbid withh >=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
• Secondary prevention based on previous large statin trials (History of
cardiovascular disease)
• Aortic disease that required a vascular repair or aortic aneurysm
• Diagnosis of familial hypercholesterolemia
• Elevated risk of death within 3 months after baseline
• Participation to a clinical trial with potential impact on the STREAM
cardiovascular endpoints
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite endpoint of major CV events (non-fatal<br /><br>myocardial infarction, non-fatal ischemic stroke) and all-cause death over a<br /><br>follow-up period of 2 years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are all-cause death, non-CV death, major CV events,<br /><br>coronary and peripheral artery revascularization, EQ-5D questionnaire, verbal<br /><br>numeric pain rating score, falls, SARC-F questionnaire and Girerd Medication<br /><br>adherence scale.</p><br>