A randomized, ongoing, open clinical trial evaluating the anti-atherosclerotic efficacy of selected antidiabetic medications in patients with coronary artery disease and pre-diabetic conditions.
Description of the study: Coronary artery disease is the most common single cause of all deaths in Poland and in other developed countries. According to 2019 data, the number of patients diagnosed with coronary artery disease was more than 2.5 million in Poland. Coronary artery disease is the most common single cause of all deaths in Poland and in other developed countries. According to 2019 data, the number of patients diagnosed with coronary artery disease was more than 2.5 million in Poland.
The cause of mortality and morbidity rate due to coronary artery disease is the progression of atherosclerosis of the coronary arteries, which most often develops in a clinically silent manner for decades before the onset of symptoms. This makes it difficult to detect it and implement appropriate preventive treatment. The recommended standard of therapeutic management for patients diagnosed with coronary artery disease includes control of cardiovascular risk factors with pharmacological treatment and modification of lifestyle and diet. The study will enroll 300 patients between the ages of 18 and 80 in the early stages of coronary artery disease that do not require surgical treatment. Participants will be regularly monitored at the center by a qualified study team consisting of a cardiologist, nutritionist and nurse. Progression of atherosclerosis will be monitored using CT scans of the coronary arteries.
Sponsor: National Institute of Cardiology
Protocol number: CSDS.IV/VIII/2023
EudraCT number: 2023-508525-27-00
Project Manager/Main Investigator: dr n. med. Jan Henzel
Duration of the study: 2023-2028
Study phase: IV
What the study concerns? cardiology