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

Table 1 Design of the SITE study

Timepoint	Study period
Timepoint	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 questionnaire^a	✓		✓	✓	✓	✓
MMSE^b	✓					✓
Consent signature		✓
Intervention		✓	✓	✓	✓	✓
Assessment
SF12 and EQ-5D-3 L Questionnaires^c		✓	✓	✓	✓	✓
Clinical examination^d	✓	✓	✓	✓	✓	✓
Biological tests^e	✓(*)		✓	✓	✓	✓
ECG^f		✓		✓	✓	✓
Clinical event data collection^g		✓	✓	✓	✓	✓
Compliance^h		✓	✓	✓	✓	✓
CVRF collectionⁱ		✓	✓	✓	✓	✓
SE/SAE collection ^j		✓	✓	✓	✓	✓

^aStandardised questionnaire with six questions to search for coronary disease history, stroke, or unnoticed peripheral artery disease
^bMini-Mental State Examination (French version, GRECO)
^cQuality of Life Questionnaire SF12 (self-administered) and EQ-5D 3 L (self-administered)
^dClinical examination: examination as recommended by good clinical practices in the field of cardiovascular medicine (blood pressure, cardiovascular (CV) data, and lung auscultation)
^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
^fECG: electrocardiogram based on recommendations (once every 3 years if permanent arterial hypertension (HTA) and once a year if overt diabetes mellitus)
^gReports of significant clinical events occurring between visits
^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)
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
^jSE/SAE: side effects and serious adverse events, respectively

ISSN: 1745-6215