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NCT Number: NCT07742488

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

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).

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Key information

Conditions

Menopausal Complaints Coagulation Tests Hypercholerolemia

Age range

45 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Santa Chiara Hospital - University Hospital of Pisa

Pisa, Italy, 56126

Location status: Recruiting

Location contact

Tommaso Simoncini - PI

CONTACT

[email protected]

+39 050992604

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Hormone replacement therapy, HRT

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.

Other names: HMG-CoA Reductase inhibitor

Primary outcomes

  1. 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

  1. HRT+Statin vs HRT only on the nAPCsr after TGA

    Time frame: From 3 months to end of study (12 months)

    Verify that the combination of statins and HRT can modify the normalized activated protein C sensitivity ratio compared to HRT alone.

  2. HRT+statins vs HRT only do not increase liver transaminases

    Time frame: From 3 months to end of study (12 months)

    Verify that the combination of statins and HRT does not have a significant impact on liver function indices (AST, ALT, GGT, all in IU/L) compared to HRT alone.

  3. HRT+statins vs HRT only on coagulation factors

    Time frame: From 3 months to end of study (12 months)

    Verify that the combination of statins and HRT can modify the expression of coagulation factors compared to HRT alone:

    • fibrinogen (mg/dl)
    • tissue factor (pg/mL)
    • thrombomodulin (ng/mL)
    • TFPI (ng/mL)
    • PAI-1 (ng/mL)

  4. HRT+statins vs HRT only on inflammatory markers

    Time frame: From 3 months to end of study (12 months)

    Verify that the combination of statins and HRT can modify the expression of inflammatory indices compared to HRT alone:

    • IL1 (pg/mL)
    • IL6 (pg/mL)
    • TNFalpha (pg/mL)

Study contacts

Contact information is provided by the study sponsor or research team.

Tommaso Simoncini

CONTACT

[email protected]

+39 050992604

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study

Acronym: STAR-HRT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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