Professor Axel Diedeirchsen Department of Cardiology, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Forventede deltagere med prøver
Inkluderede deltagere med prøver
The effects of Menaquinone-7 supplementation in patients with severe coronary calcifications
Acronym: The DANish COronary DEcalcification (DANCODE) trial
Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. Supplementation with vitamin K2 and D has been suggested to have a protective role in the progression of CAC. In this study, we will examine the effect of vitamin K2 and D in men and women with severe CAC. We hypothesize that supplementation with vitamin K2 and D will slow down the calcification process
Description of the cohort
In this multicenter and double-blinded placebo-controlled study, 400 men and women with CAC score ≥ 400 are randomized (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D (25 µg/day) or placebo treatment (no active treatment) for two years. Among exclusion criteria are treatment with vitamin K antagonist, coagulation disorders and prior coronary artery disease. Primary outcome is progression in CAC score from baseline to follow-up at two years. Among secondary outcomes are coronary plaque composition and cardiac events. Intention-to-treat principle is used for all analyses.
Data and biological material
To evaluate progression in coronary plaque, a cardiac CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up.
A biobank, including blood samples at baseline and at two years of follow-up, is established.