Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia

ConditionsMenopausal Complaints Hypercholerolemia Coagulation Tests

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age45-55

SponsorUniversity of Pisa

About this trial

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:

1. does hormone replacement therapy affect the coagulation profile? 2. 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? 3. 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Women aged 45-55 years in menopause who have symptoms requiring oral HRT (and with no contraindications according to national and international guidelines), who present with low-moderate cardiovascular risk, and who have recently been diagnosed with dyslipidemia but have not yet undergone treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

estroprogestins
Drug
To be included in the study, patients must have menopausal symptoms requiring hormone replacement therapy without contraindications to it. All cohorts will undergo this therapy.
Statin
Drug
After 3 months, patients not controlling hypercholesterolemia with lifestyle changes will be prescribed statin as per clinical routine practice. They will be part of the HRT+statin cohort.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: HRT+statin2 interventions

Group B: HRT only1 intervention

Trial outcomes

Primary outcomes

HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay

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.

Time frame