The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
时间窗: 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.
次要结局
- 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))
研究者
Tommaso Simoncini
Professor
University of Pisa