Effects of statins and hormone therapy on coagulation in menopausal women with high cholesterol
Official title: The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
Run by University of Pisa · NCT07742488 · Data updated 2026-11-12
This study tests whether adding a statin to estrogen-progestin hormone therapy changes the blood’s clotting profile in menopausal women with high cholesterol who need hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years to 55 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa, Italy) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07742488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 45-55 who are early postmenopausal, require oral estrogen-progestin HRT, have low-to-moderate cardiovascular risk, and LDL above target for their risk class.
✕Probably not a fit
Women who are not starting HRT or statin therapy, have high-risk cardiovascular profiles, or have contraindications to the studied therapies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates how oral estrogen-progestin hormone therapy and statin treatment might influence coagulation tests, overall inflammation, and liver safety in menopausal women with dyslipidemia. Participants are enrolled before starting any therapy if hormone replacement is indicated and dyslipidemia is present, and they will be followed to observe changes in coagulation markers and safety signals. The study will also explore whether statins can reverse coagulation alterations that may occur after initiating hormone therapy. Data will be collected from a single Italian center to characterize associations and safety in a real-world setting.
Why it matters
Potential benefit: If successful, findings could help guide safer use of hormone therapy with lipid-lowering treatment in menopausal women at risk of coagulation changes.
How similar studies have gone: Prior studies have explored coagulation changes with hormone therapy and lipid-lowering therapy, but this specific combination in this population is less well characterized and represents a more targeted, real-world assessment.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Santa Chiara Hospital - University Hospital of Pisa
Pisa, Italy, Italy Recruiting
Study contacts
- Study coordinator: Tommaso Simoncini
- Email: tommaso.simoncini@unipi.it
- Phone: +39 050992604
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.