Statins to Prevent Immune checkpoint inhibitor-induced pRogression of AtheroscLerosis

Conditions

Atherosclerosis

Brief summary

Annualized percentage change in non-calcified atherosclerotic plaque volume in the descending thoracic aorta in the intervention versus the control group.

Detailed description

Annualized percentage change in total and calcified atherosclerotic plaque volume in the thoracic aorta in the intervention versus the control group, Annualized percentage change in total, non-calcified and calcified coronary artery atherosclerotic plaque volume in the intervention versus the control group., Annualized change in coronary calcification score (Agatston score) and MESA score in the intervention versus the control group., Annualized change in epicardial fat volume in the intervention versus the control group p, Difference in reactive hyperaemia index as a marker of endothelial dysfunction using peripheral arterial tonometry (EndoPAT) between intervention and control group., Difference in quality of life between intervention and control group at baseline, 3 months, 6 months and 1 year after the start of ICI therapy, Differences in the number of adverse events between intervention and control group during the first year after start of ICI therapy, graded according to CTCAE criteria, version 5.0.

Related papers

No related papers found yet.

Interventions

DRUGATORVASTATIN

DRUGPLACEBO

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized percentage change in non-calcified atherosclerotic plaque volume in the descending thoracic aorta in the intervention versus the control group.	—

Secondary

Measure	Time frame
Annualized percentage change in total and calcified atherosclerotic plaque volume in the thoracic aorta in the intervention versus the control group, Annualized percentage change in total, non-calcified and calcified coronary artery atherosclerotic plaque volume in the intervention versus the control group., Annualized change in coronary calcification score (Agatston score) and MESA score in the intervention versus the control group., Annualized change in epicardial fat volume in the intervention versus the control group p, Difference in reactive hyperaemia index as a marker of endothelial dysfunction using peripheral arterial tonometry (EndoPAT) between intervention and control group., Difference in quality of life between intervention and control group at baseline, 3 months, 6 months and 1 year after the start of ICI therapy, Differences in the number of adverse events between intervention and control group during the first year after start of ICI therapy, graded according to CTCAE c	—

Measure

Time frame

Annualized percentage change in total and calcified atherosclerotic plaque volume in the thoracic aorta in the intervention versus the control group, Annualized percentage change in total, non-calcified and calcified coronary artery atherosclerotic plaque volume in the intervention versus the control group., Annualized change in coronary calcification score (Agatston score) and MESA score in the intervention versus the control group., Annualized change in epicardial fat volume in the intervention versus the control group p, Difference in reactive hyperaemia index as a marker of endothelial dysfunction using peripheral arterial tonometry (EndoPAT) between intervention and control group., Difference in quality of life between intervention and control group at baseline, 3 months, 6 months and 1 year after the start of ICI therapy, Differences in the number of adverse events between intervention and control group during the first year after start of ICI therapy, graded according to CTCAE c

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Countries

Netherlands

Outcome results

None listed