2023-504654-35-00招募中2 期
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) with Atorvastatin (ATORGO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 554
- 试验地点
- 7
- 主要终点
- The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.
研究概览
简要总结
The primary objective of this trial is to determine if atorvastatin can prevent the development of active GO in patients newly diagnosed with GD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18–85 years
- •Diagnosis of Graves' Disease (GD):TSH < 0.1 μU/L. Elevated free T4 (fT4) and/or free T3 (fT3). Positive TSH receptor antibodies (TRAb).
- •Sufficient knowledge of Swedish to understand medical information and participate in telephone or video calls.
排除标准
- •Pregnancy, planned pregnancy within 12 months or lactation
- •Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers.
- •Need of corticosteroid protection for planned radioiodine therapy
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial
- •Prior treatment with statins, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding GD diagnosis.
- •Existing Graves' Ophthalmopathy (GO) at the time of GD diagnosis.
- •Known hypersensitivity to atorvastatin or other statins.
- •Active liver disease.
- •Alcohol abuse.
- •Elevated liver enzymes (ASAT/ALAT > 3 times the upper normal limit in two consecutive tests).
结局指标
主要结局
The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.
The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.
次要结局
- Proportion of patients developing clinical GO at 3, 6, 9, 15, and 18 months.
- Time from GD diagnosis to GO onset.
- Highest CAS recorded during the study period.
- Proportion of patients requiring interventions such as corticosteroids, orbital irradiation, or biologics (e.g., rituximab or teprotumumab).
- Change in quality-of-life scores as measured by validated tools, including GO-QoL and Thyr-Pro questionnaires, at baseline, 12 months, and 18 months.
- Levels of TSH-receptor antibodies (TRAb) at 12 and 18 months
- Identification of new GO-related biomarkers using proteomics and microarray analysis.
- Genetic differences between responders and non-responders to atorvastatin, identified via genome-wide association studies (GWAS) and analyses of relevant single nucleotide polymorphisms (SNPs).
研究者
Tereza Planck
Scientific
Region Skane
研究点 (7)
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