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Not Yet Recruiting NCT07883356

Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)

Conditions: Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy, Graves Ophthalmopathy, Graves' Orbitopathy, Graves' Disease, Graves' Hyperthyroidism, Graves´ Disease, Graves´ Ophthalmopathy, Graves' Ophthalmopathy (GO), Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid-Associated Ophthalmopathy

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 554
Sponsor: Region Skane

Location: Sahlgrenska University Hospital Gothenburg

Summary

Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye discomfort, double vision, changes in appearance, and, in severe cases, problems with vision. The purpose of this study is to find out whether atorvastatin, a commonly used cholesterol-lowering medicine, can reduce the risk of developing active thyroid eye disease in adults who have recently been diagnosed with Graves' disease. A total of 554 participants will be randomly assigned to one of two groups. One group will receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for Graves' disease. The other group will receive standard treatment for Graves' disease alone. Participants will be followed for 18 months. During the study, participants will have regular assessments of their thyroid disease and their eyes. Blood samples and questionnaires about symptoms and quality of life will also be collected. The researchers will compare the two groups to determine whether atorvastatin reduces the development of active thyroid eye disease.

Eligibility Criteria

Inclusion Criteria: * Age 18-85 years. * Newly diagnosed Graves' disease, defined as TSH \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07883356). StuddyBuddy aggregates publicly available trial information.