Circulatory System Nutritional, Metabolic, Endocrine Cardiology
Conditions
Interventions
Combination Therapy of Ezetimibe 10 mg plus Atorvastatin 10 mg
Monotherapy Atorvastatin 40 mg
Sponsors
University Military Hospital of Sfax
Laboratoires THERA pharmaceutiques
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Indication for Statin Therapy • Adults (=18 years) with one of the following conditions: o Hypertension. o Dyslipidemia. o Diabetes mellitus (type 1 or type 2) or prediabetes. o Obesity (BMI =30 kg/m²). • at high or very high cardiovascular risk according to the Tunisian INEAS guidelines, on cardiovascular prevention , Hypertension , on type 2 diabetes , dyslipidemia • and in whom a reduction of LDL-C by 30% to 50%, is indicated, according to the same guidelines. ? Lipid Lowering agents-Naïve Status No prior treatment with statins or other lipid-lowering agents within the past 3 months (to ensure baseline lipid profile is unaffected by recent therapy). ? Baseline Lipid Profile Availability Documented fasting lipid profile within the last 4 weeks before randomization, demonstrating LDL-C levels that correspond to the indicated reduction goal (30–50%). ? Age and Sex • Men or women aged =18 years. • Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study period. ? Consent Signed and dated written informed consent obtained before initiation of any study-specific procedures, after full explanation of the study purpose, procedures, potential benefits, and risks.
Exclusion criteria
Exclusion criteria: • Non-adherence to treatment • Documented history of atherosclerotic cardiovascular disease (ASCVD), between inclusion and randomization, including: Myocardial infarction, Angina pectoris (stable or unstable), Coronary revascularization (PCI or CABG), Stroke or transient ischemic attack (TIA), Peripheral arterial disease • Withdrawal of the treatment because of side effects or pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL-C level | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in non-HDL-C, and hs-CRP levels from T0 to T3 Incidence of major cardiovascular events (stroke, myocardial infarction, revascularization, hospitalization for unstable angina or heart failure) Safety and tolerability outcomes: include elevation of CPK to more than five times the upper limit of normal, the occurrence of myalgias or myositis, hepatic dysfunction defined as transaminase levels exceeding three times the upper limit of normal, changes in renal function, and the development of new-onset type 2 diabetes | — |
Countries
Tunisia
Contacts
Public ContactRania HAMMAMI
Head of the Cardiology Departement at the University Military Hospital of Sfax
Outcome results
None listed