drugset / Trial / NCT05998525

Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography

NCT05998525

Phase 3 Completed 54 enrolled Hilda Elizabeth Macías Cervantes
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Calcification of the coronary arteries is a direct sign of atherosclerotic disease of the coronary arteries and has been shown to be a strong predictor of the risk of cardiovascular diseases, including myocardial infarction and/or cardiac death, especially in patients with Diabetes Mellitus type 2. Therefore, there is great interest in pharmacotherapies that improve the rates of cardiovascular complications, and modify the outcomes of this group of patients. Large randomized controlled trials with SGLT2 inhibitors in patients with DM2 have shown a clear reduction in cardiovascular events among individuals with atherosclerotic disease. Atherosclerosis imaging allows measurable assessments of disease progression and activity, revealing early signs of potential drug effects. Noninvasive methods are preferred for serial imaging in drug trials due to the potential risks associated with invasive procedures. The coronary artery calcium quantification using the Agatston score is the most widely used method

Timeline

Start
2021-06-21
Primary completion
2022-12-30
Completion
2023-06-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral