Statins In The Elderly (SITE)
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| ClinicalTrials.gov Identifier: NCT02547883 |
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Recruitment Status :
Completed
First Posted : September 11, 2015
Last Update Posted : February 24, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | September 10, 2015 | |||||||||
| First Posted Date ICMJE | September 11, 2015 | |||||||||
| Last Update Posted Date | February 24, 2023 | |||||||||
| Actual Study Start Date ICMJE | June 15, 2016 | |||||||||
| Actual Primary Completion Date | January 31, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Statins In The Elderly | |||||||||
| Official Title ICMJE | Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial | |||||||||
| Brief 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. 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. |
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| 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 |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Mortality | |||||||||
| Intervention ICMJE | Drug: Cessation of statin
The intervention evaluated is the cessation of statin
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
1230 | |||||||||
| Original Estimated Enrollment ICMJE |
2430 | |||||||||
| Actual Study Completion Date ICMJE | January 31, 2023 | |||||||||
| Actual Primary Completion Date | January 31, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 75 Years and older (Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02547883 | |||||||||
| Other Study ID Numbers ICMJE | CHUBX 2014/41 PRME 14-0037 ( Other Grant/Funding Number: French minister of Health ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | University Hospital, Bordeaux | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | University Hospital, Bordeaux | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Bordeaux | |||||||||
| Verification Date | February 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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