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Table 1 Design of the SITE study

From: Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial

TimepointStudy period
Pre-inclusion
T − 1
Inclusion
T 0
M3
+/−  1 month
M12
+/− 3 months
M24
+/−  3 months
Close-out
M36
+/−  3 months
Enrolment
 Information/eligibility screen     
 Standardised questionnairea 
 MMSEb    
 Consent signature     
Intervention 
Assessment
 SF12 and EQ-5D-3 L Questionnairesc 
 Clinical examinationd
 Biological testse(*) 
 ECGf  
 Clinical event data collectiong 
 Complianceh 
 CVRF collectioni 
 SE/SAE collection j 
  1. aStandardised questionnaire with six questions to search for coronary disease history, stroke, or unnoticed peripheral artery disease
  2. bMini-Mental State Examination (French version, GRECO)
  3. cQuality of Life Questionnaire SF12 (self-administered) and EQ-5D 3 L (self-administered)
  4. dClinical examination: examination as recommended by good clinical practices in the field of cardiovascular medicine (blood pressure, cardiovascular (CV) data, and lung auscultation)
  5. eLaboratory tests: lipid (EAL), blood glucose, HbA1c (if diabetic), electrolytes, creatinine, creatinine clearance, and serum albumin. *In the absence of a balance sheet dated within 12 months before pre-inclusion, laboratory tests are prescribed at pre-inclusion and should be performed until the day of the inclusion visit
  6. fECG: electrocardiogram based on recommendations (once every 3 years if permanent arterial hypertension (HTA) and once a year if overt diabetes mellitus)
  7. gReports of significant clinical events occurring between visits
  8. hCompliance assessed by Morisky questionnaire (eight items) at baseline (all patients) and during follow up (only in the group of patients in whom statin therapy is continued)
  9. iTotal CV risk factors: weight, waist circumference, smoking, hypertension, diabetes mellitus, previous family history of CV disease among first-degree relatives, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol
  10. jSE/SAE: side effects and serious adverse events, respectively