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Statins In The Elderly (SITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547883
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.


Condition or disease Intervention/treatment Phase
Mortality Drug: Cessation of statin Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : January 31, 2023
Actual Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients stopping statin Drug: Cessation of statin
The intervention evaluated is the cessation of statin
No Intervention: Patients continuing statin


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Overall mortality [ Time Frame: 36 month after inclusion ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3, 12, 24 and 36 moth after inclusion ]
    Quality of life as measured by the SF12

  2. Clinical events occurence [ Time Frame: 3, 12, 24 and 36 moth after inclusion ]
    Clinical events: cardiovascular events, diabetes, cognitive disorders


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Life prognosis below 6 months
  • Patient with known homozygous or double heterozygous familial hypercholesterolemia
  • Dementia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547883


Locations
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France
CHU de Bordeaux
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Antoine BENARD USMR - CHU de Bordeaux
Principal Investigator: Jean-philippe JOSEPH, Pr Bordeaux university
Study Director: Fabrice BONNET, Pr University Hospital, Bordeaux
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02547883    
Other Study ID Numbers: CHUBX 2014/41
PRME 14-0037 ( Other Grant/Funding Number: French minister of Health )
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023
Keywords provided by University Hospital, Bordeaux:
Statins
Elderly
Mortality
Quality of life
 Randomized trial
Cost effectiveness study
Primary care