Early TRIPLE versus dual LIPID lowering treatment in peOple with atherosclerotic cardiovascular disease and hypercholesterolemia Undergoing elecTive revascularisation - The randomized, controlled, open-label, parallel group TRIPLE-LIPID-OUT trial

Conditions

Coronary artery atherosclerotic heart disease, Hypercholesterolaemia, Peripheral arterial disease

Brief summary

Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 weeks (V2) between the two study groups

Detailed description

Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 months follow up between the two study groups, Difference in mean change of LDL-C levels between the two study groups from V1 to V2, Difference in mean change of LDL-C levels between the two study groups from V1 to 12 months, Difference in mean change of Apo-B100 levels between the two study groups from V1 to V2, Difference in mean change of Apo-B100 levels between the two study groups from V1 to 12months, Difference in mean change of Apo-A1 levels between the two study groups from V1 to V2, Difference in mean change of Apo-A1 levels between the two study groups from V1 to 12 months, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1 to V2, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1to 12 months, Difference in mean change of hs-CRP levels between the two study groups from V1 to V2, Difference in mean change of hs-CRP levels between the two study groups from V1 to 12 months, Difference in number of severe adverse events (SAEs) between the two groups from V1 over 12 months, Difference in the Depression Score (HADS-D) between the two groups from V1 to V2, Difference in the Depression Score (HADS-D) between the two groups from V1 to 12 months, Difference in the psychological flexibility between the two groups from V1 to V2, Difference in the psychological flexibility between the two groups from V1 to 12 months, Difference in the number of adverse events between the two groups from V1 to V2, Difference in the number of adverse events between the two groups from V1 to 12 months

Related papers

No related papers found yet.

Interventions

DRUGEzegelan 10 mg-Tabletten

DRUGNustendi 180 mg/10 mg film-coated tablets

DRUGRosuvalan 20 mg-Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 weeks (V2) between the two study groups	—

Secondary

Measure	Time frame
Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 months follow up between the two study groups, Difference in mean change of LDL-C levels between the two study groups from V1 to V2, Difference in mean change of LDL-C levels between the two study groups from V1 to 12 months, Difference in mean change of Apo-B100 levels between the two study groups from V1 to V2, Difference in mean change of Apo-B100 levels between the two study groups from V1 to 12months, Difference in mean change of Apo-A1 levels between the two study groups from V1 to V2, Difference in mean change of Apo-A1 levels between the two study groups from V1 to 12 months, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1 to V2, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1to 12 months, Difference in mean change of hs-CRP levels between the two study groups from V1 to V2, Difference in mean change of hs-CRP levels b	—

Measure

Time frame

Difference in the percentage of people achieving an LDL-C <55 mg/dl at 12 months follow up between the two study groups, Difference in mean change of LDL-C levels between the two study groups from V1 to V2, Difference in mean change of LDL-C levels between the two study groups from V1 to 12 months, Difference in mean change of Apo-B100 levels between the two study groups from V1 to V2, Difference in mean change of Apo-B100 levels between the two study groups from V1 to 12months, Difference in mean change of Apo-A1 levels between the two study groups from V1 to V2, Difference in mean change of Apo-A1 levels between the two study groups from V1 to 12 months, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1 to V2, Difference in mean change of apolipoprotein (a) levels between the two study groups from V1to 12 months, Difference in mean change of hs-CRP levels between the two study groups from V1 to V2, Difference in mean change of hs-CRP levels b

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Outcome results

None listed