The primary objective is to compare a composite endpoint of major CV events and all-cause death between control and intervention group.Secondary objectives are the comparison of patient-centered outcomes between the two groups.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite endpoint of major CV events (non-fatal
myocardial infarction, non-fatal ischemic stroke) and all-cause death over a
follow-up period of 2 years.
Secondary outcome
Secondary endpoints are all-cause death, non-CV death, major CV events,
coronary and peripheral artery revascularization, EQ-5D questionnaire, verbal
numeric pain rating score, falls, SARC-F questionnaire and Girerd Medication
adherence scale.
Background 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 people
(aged >=70) without CVD are uncertain, particularly for those with
multimorbidity. However, statin side effects and drug interactions are common
in a multimorbid elderly population and can negatively impact quality of life
and increase adverse drug reaction-related hospitalizations. Therefore, we aim
to conduct a statin deprescribing randomized controlled trial (RCT) to provide
guidance on the long-term benefits and risks for the ever-growing multimorbid
elderly population.
Study objective
The primary objective is to compare a composite endpoint of major CV events and
all-cause death between control and intervention group.
Secondary objectives are the comparison of patient-centered outcomes between
the two groups.
Study design
The study is a multicenter, randomized, non-inferiority trial. The study is
open-labelled, with blinded outcome adjudication. Study subjects are randomly
assigned in a 1:1 ratio to either discontinue (intervention arm) or continue
(control arm) statin therapy.
Intervention
In the intervention group, statin therapy will be stopped
Study burden and risks
Potential risks of discontinuing statins might include increased CV events.
However, current trials found no benefits of statins after 70 years of age for
primary prevention. In the multimorbid elderly, statin side effects and drug
interactions are common and discontinuing statin might positively impact
quality of life.
Freiburgstrasse 18
Bern CH-3010
CH
Freiburgstrasse 18
Bern CH-3010
CH
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05178420 |
| CCMO | NL83907.058.23 |