Utility of Coronary Artery Calcification With Statin Therapy in Multimorbid Older Adults - An Ancillary Study Nested Within a Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 adults (aged ≥70 years) without CVD are uncertain, particularly for those with multimorbidity. To better target adults who may benefit from statins in primary prevention, coronary artery calcium (CAC) measurement is rapidly increasing in clinical use and is recommended for risk re-classification in some guidelines. Older patients with a high burden of subclinical atherosclerosis might benefit from continuing statins to prevent CV outcomes, but this hypothesis has not been rigorously tested in randomized clinical trials (RCTs). To address these questions, the investigators conduct a RCT in 500 multimorbid adults ≥70 years old taking statins for primary prevention who will be randomized to statin continuation vs. statin discontinuation, and measure baseline CAC to determine if the risk of a composite outcome of CV events and all-cause mortality after statin discontinuation differs among those with evidence of subclinical atherosclerosis at baseline as measured by CAC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
Switzerland
University Hospital of Bern, University of Bern
RECRUITING
Bern
Contact Information
Primary
Manuel R Blum, MD, MSc
manuel.blum@insel.ch
+41 31 632 21 11
Backup
Nicolas Rodondi, MD, MAS
nicolas.rodondi@insel.ch
+41 31 632 00 69
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2026-11
Participants
Target number of participants: 500
Treatments
Experimental: Statin discontinuation
Discontinuation of statin therapy - statin therapy will be stopped from the next scheduled intake after study inclusion (intervention arm).
No_intervention: Statin continuation
Continuation of statin therapy - no change in the prescribed statin therapy (control arm).
Related Therapeutic Areas
Sponsors
Collaborators: University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov

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