MortalitySITENCT02547883
Statins In The Elderly
A study testing Cessation of statin in people with Mortality, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Mortality
- What is being tested?
- Cessation of statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2016to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People aged ≥ 75 years
- Treated with any statin from at least one year, in primary prevention
- Having replied to a standardized questionnaire allowing to screen any history of cardiovascular event
- Consent form signed
Who cannot join
- Life prognosis below 6 months
- Patient with known homozygous or double heterozygous familial hypercholesterolemia
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the French healthcare system.
The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.
Read the detailed description
Statins in primary prevention are associated with a 1.2% decreased absolute risk of cardiovascular events in large randomized studies. Anyway, in patients ≥ 75 years, the impact of statins on mortality have not been demonstrated and large observational studies have shown an increased risk of mortality in people with low cholesterol. Moreover, statins are associated with numerous side effects, particularly in the elderly including myalgia and myositis, diabetes, cognitive disorders, fatigue and loss of energy and of physical activities, treatment interactions. At last, the cost of statins for the French national health insurance is 800 million euros per year (including around 200 million euros for people ≥ 75 years).
The benefit/risk ratio of statins is not established in primary prevention in people ≥ 75 years, leading to numerous and discordant expert advices since no specific randomized trial have been conducted in this population.
Thus, in patients ≥ 75 years treated with statins in primary prevention, the studied strategy will be to stop statin therapy. The comparison strategy will be represented by the group of patient who will continue their statin at the same dose.
Patients will be followed up every three months, according to general recommendations, during 36 months. Clinical events will be prospectively registered
- Conditions
- Mortality
- Being tested
- Cessation of statin
- Keywords
- Statins, Elderly, Mortality, Quality of life, Randomized trial, Cost effectiveness study, Primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation of statinDrug
The intervention evaluated is the cessation of statin
| Study group | Role | What they receive |
|---|---|---|
| Patients stopping statin | Experimental | Not described Receives: Drug: Cessation of statin |
| Patients continuing statin | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost per QALY gained
Ratio between QALYs (quality-adjusted life years) gained estimated by the EQ-5D scale and cost for the French healthcare system
Measured: 36 month after inclusion
Overall mortality
Measured: 36 month after inclusion
Secondary outcomes (2)
Quality of life
Quality of life as measured by the SF12
Measured: 3, 12, 24 and 36 moth after inclusion
Clinical events occurence
Clinical events: cardiovascular events, diabetes, cognitive disorders
Measured: 3, 12, 24 and 36 moth after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start15 Jun 2016
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, Study chair, USMR - CHU de BordeauxJean-philippe JOSEPH, Pr, Principal investigator, University of BordeauxFabrice BONNET, Pr, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547883
- Sponsor's protocol ID
- CHUBX 2014/41
- Other IDs
- PRME 14-0037
- Acronym
- SITE
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2015
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonnet F, Poulizac P, Rousselot N, Couffinhal T, Galli G, Berdai D, Vandenhende MA, Rousset M, Coueron R, Benard A, Joseph JP; SAGA/SITE Study Group. Discontinuation of statins for primary prevention of atherosclerotic cardiovascular disease in adults aged 75 years or older (SAGA/SITE): a multicentre, open-label, pragmatic, non-inferiority randomised trial. Lancet Healthy Longev. 2027 Jun 30:100884. doi: 10.1016/j.lanhl.2026.100884. Online ahead of print.
PubMed 42580354Bonnet F, Benard A, Poulizac P, Afonso M, Maillard A, Salvo F, Berdai D, Salles N, Rousselot N, Marchi S, Hayes N, Joseph JP. Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.
PubMed 32307005Bonnet F, Poulizac P, Joseph JP. Safety and efficacy of statins. Lancet. 2017 Mar 18;389(10074):1097-1098. doi: 10.1016/S0140-6736(17)30712-2. No abstract available.
PubMed 28322812
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT02547883
- Acronym / sponsor ID
- SITE / CHUBX 2014/41
- Conditions
- Mortality
- Keywords
- Statins, Elderly, Mortality, Quality of life, Randomized trial, Cost effectiveness study, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the French healthcare system.
The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.
Detailed description
Statins in primary prevention are associated with a 1.2% decreased absolute risk of cardiovascular events in large randomized studies. Anyway, in patients ≥ 75 years, the impact of statins on mortality have not been demonstrated and large observational studies have shown an increased risk of mortality in people with low cholesterol. Moreover, statins are associated with numerous side effects, particularly in the elderly including myalgia and myositis, diabetes, cognitive disorders, fatigue and loss of energy and of physical activities, treatment interactions. At last, the cost of statins for the French national health insurance is 800 million euros per year (including around 200 million euros for people ≥ 75 years).
The benefit/risk ratio of statins is not established in primary prevention in people ≥ 75 years, leading to numerous and discordant expert advices since no specific randomized trial have been conducted in this population.
Thus, in patients ≥ 75 years treated with statins in primary prevention, the studied strategy will be to stop statin therapy. The comparison strategy will be represented by the group of patient who will continue their statin at the same dose.
Patients will be followed up every three months, according to general recommendations, during 36 months. Clinical events will be prospectively registered
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients stopping statin | Experimental | Drug: Cessation of statin |
| Patients continuing statin | No intervention | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- People aged ≥ 75 years
- Treated with any statin from at least one year, in primary prevention
- Having replied to a standardized questionnaire allowing to screen any history of cardiovascular event
- Consent form signed
Key exclusion criteria (3 listed)
- Life prognosis below 6 months
- Patient with known homozygous or double heterozygous familial hypercholesterolemia
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation of statinThe intervention evaluated is the cessation of statin | Drug | Patients stopping statin |
Primary outcome
Incremental Cost per QALY gained
Time frame: 36 month after inclusion
Ratio between QALYs (quality-adjusted life years) gained estimated by the EQ-5D scale and cost for the French healthcare system
Overall mortality
Time frame: 36 month after inclusion
2 secondary outcomes
Quality of life
Time frame: 3, 12, 24 and 36 moth after inclusion
Clinical events occurence
Time frame: 3, 12, 24 and 36 moth after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 42580354Bonnet F, Poulizac P, Rousselot N, Couffinhal T, Galli G, Berdai D, Vandenhende MA, Rousset M, Coueron R, Benard A, Joseph JP; SAGA/SITE Study Group. Discontinuation of statins for primary prevention of atherosclerotic cardiovascular disease in adults aged 75 years or older (SAGA/SITE): a multicentre, open-label, pragmatic, non-inferiority randomised trial. Lancet Healthy Longev. 2027 Jun 30:100884. doi: 10.1016/j.lanhl.2026.100884. Online ahead of print.
- Derived from this study: PubMed 32307005Bonnet F, Benard A, Poulizac P, Afonso M, Maillard A, Salvo F, Berdai D, Salles N, Rousselot N, Marchi S, Hayes N, Joseph JP. Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.
- Derived from this study: PubMed 28322812Bonnet F, Poulizac P, Joseph JP. Safety and efficacy of statins. Lancet. 2017 Mar 18;389(10074):1097-1098. doi: 10.1016/S0140-6736(17)30712-2. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine BENARD study chair
USMR - CHU de Bordeaux
Jean-philippe JOSEPH, Pr principal investigator
University of Bordeaux
Fabrice BONNET, Pr study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation of statin in people with Mortality, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost per QALY gained (time frame: 36 month after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.