Cardiac allograft vaculopathy in recent heart transplant recipients
Conditions
Brief summary
Mean level of LDL-C, HDL-C, TC, TG, ApoB, Lp[a], ApoA1 at treatment visit 2, 3, 4, 5 and 6.
Detailed description
Percent change from baseline in calculated LDL-C at Treatment visit 6, Calculated LDL-cholesterol at every study visit (Treatment visit 1, 2, 3, 4, 5, and Visit 6), Difference in other lipids and lipoproteins (TC, HDL-C, ApoB, ApoA1, Lp(a), TG) at every study visit (Treatment visit 1, 2, 3, 4, 5, and Visit 6), Change of LDL-C and the other parameters of lipid profile (TC, HDL-C, ApoB, ApoA1, Lp(a), TG) between Treatment visit 6 and Visit 7, Difference in mean of intimal thickness change (between Treatment visit 6 – Treatment visit 1) assessed by OCT, Difference in mean lumen volume change (between Treatment visit 6 – Treatment visit 1) assessed by OCT.
Interventions
DRUGAlirocumab
DRUGPlacebo product for REGN727
Sponsors
Institute For Clinical And Experimental Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean level of LDL-C, HDL-C, TC, TG, ApoB, Lp[a], ApoA1 at treatment visit 2, 3, 4, 5 and 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in calculated LDL-C at Treatment visit 6, Calculated LDL-cholesterol at every study visit (Treatment visit 1, 2, 3, 4, 5, and Visit 6), Difference in other lipids and lipoproteins (TC, HDL-C, ApoB, ApoA1, Lp(a), TG) at every study visit (Treatment visit 1, 2, 3, 4, 5, and Visit 6), Change of LDL-C and the other parameters of lipid profile (TC, HDL-C, ApoB, ApoA1, Lp(a), TG) between Treatment visit 6 and Visit 7, Difference in mean of intimal thickness change (between Treatment visit 6 – Treatment visit 1) assessed by OCT, Difference in mean lumen volume change (between Treatment visit 6 – Treatment visit 1) assessed by OCT. | — |
Countries
Czechia
Outcome results
None listed