The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pisa
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
Study Overview
Brief Summary
The goal of this study is to understand whether statin therapy, a common lipid-lowering therapy, may improve the coagulation profile of menopausal women with hypercholesterolemia undergoing hormone replacement therapy with oral estroprogestin. It will also learn about the liver safety of the combination. The main questions will be:
- does hormone replacement therapy affect the coagulation profile?
- when we add statin therapy due to hypercholesterolemia not improving with lifestyle, does it reverse eventual changes of the coagulation profile occurred after initiation of hormone replacement therapy?
- do the two therapies have an effect on overall inflammation of the organism?
Participants will be asked to participate to the study before starting any therapy, if they need hormone relacement therapy due to symptoms, if they have a new onset of dyslipidemia and if they do not have contraindications to the therapies object of the study. The study is observational, thus it will not affect in any way the clinical care, which will follow only guidelines. During routine blood sample collection, additional aliquotes will be taken for the study at the recruitment, after 3 months of hormone replacement therapy and lifestyle changes, at the end of the study (after one year from the recruitment).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged between 45 and 55
- •Early postmenopausal period (within 5 years of the last menstrual cycle).
- •Prescription of oral estrogen-progestin HRT for symptoms that require it according to current guidelines
- •Low-moderate cardiovascular risk (SCORE2 calculation and assessment based on age)
- •LDL levels above target according to the class of risk
Exclusion Criteria
- •Recent pregnancy (<1 year) or current breastfeeding
- •Ongoing therapies that interfere with the study objectives: HRT or other estroprogestin therapy, lipid-lowering drugs, anticoagulants, or antiplatelet agents
- •Current or previous venous or arterial thrombotic event
- •Diagnosis of cancer for which treatment is ongoing or has been discontinued for less than 10 years
- •Known hereditary thrombophilia
- •Chronic inflammatory bowel disease
- •Diabetes mellitus
- •Body mass index (BMI) > 30 kg/m²
- •Acute/chronic liver failure or abnormal liver enzymes (ALT or AST > 100 IU/L; GGT > 100 IU/L; alkaline phosphatase > 250 IU/L)
- •Other known risk factors for VTE or contraindications to HRT
- •Refusal to take HRT
Outcomes
Primary Outcomes
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
Time Frame: From 3 months to end of study (12 months)
Verify that the combination of statins and hormone replacement therapy (HRT) in symptomatic menopausal patients with cholesterol levels not at target induces an improvement in the venous thromboembolic (VTE) risk profile in terms of improvement in the endogenous thrombin potential (ETP) of the thrombin generation assay (TGA) compared to HRT alone.
Secondary Outcomes
- HRT+Statin vs HRT only on the nAPCsr after TGA(From 3 months to end of study (12 months))
- HRT+statins vs HRT only do not increase liver transaminases(From 3 months to end of study (12 months))
- HRT+statins vs HRT only on coagulation factors(From 3 months to end of study (12 months))
- HRT+statins vs HRT only on inflammatory markers(From 3 months to end of study (12 months))
Investigators
Tommaso Simoncini
Professor
University of Pisa