platelet activity and inflammation markers in patients with coronary artery disease
Conditions
Interventions
Trade Name: Leqvio
Product Name: Inclisiran
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Inclisiran
Other descriptive name: Leqvio
Concentration unit: mg mill
Sponsors
Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age = 18 and =85 years • ability to give informed consent • patients in stable clinical condition and with documented CAD: a history of acute myocardial infarction (MI), or elective percutaneous coronary revascularisation procedures 4-6 weeks prior to study inclusion • patients on dual antiplatelet therapy due to CAD (the combination of P2Y12-inhibitor: clopidogrel/ prasugrel/ ticagrelor and ASA) during the whole length of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • age 85 years • relevant hematologic deviations (hemoglobin 600 × 109 cells/l) • patients with a known platelet disorder • history of alcohol or drug addiction • pregnancy or breastfeeding • inability to give informed consent • chronic use of anti-inflammatory drugs • chronic use of systemic corticosteroids • use of fibrates, niacin and derivatives, bile acid sequestrants, mipomersen, lomitapide, cholesteryl ester transfer protein inhibitors, or red yeast rice containing products or undergoing apheresis during the study or within specified intervals before a screening • total fasting triglycerides (TG) of 500 mg/dL or greater • expected life expectancy less than one year • patients currently on or with planned oral anticoagulation within the study period • patients with planned percutaneous coronary intervention or coronary artery bypass surgery at the time of study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the potential pleiotropic effects on inflammatory markers and platelet activation of treatment with Inclisiran, Bempedoic acid and Evelocumab.;Secondary Objective: The secondary endpoints are: -The correlation between the lipid panel and inflammation markers. -The correlation between the lipid panel and platelet activity. -The correlation between patients amount of body fat and inflammation markers. -The correlation between patients amount of body fat and platelet activity. -Change of the platelet activity, inflammation markers and lipid profile in time after beginning of treatment. ;Primary end point(s): 4.1.1Co-primary endpoints 1.Changes in platelet function measured with Multiplate analyser and flow cytometry-based on monocyte-platelet aggregates caused after initiation of treatment. 2.Change in the inflammatory state based on the measurement of anti- and pro-inflammatory markers caused after initiation of treatment. 3.Velocity of changes in the lipid profile after initiation of treatment. ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - The correlation between the lipid panel and inflammation markers. - The correlation between the lipid panel and platelet activity. - The correlation between patients amount of body fat and inflammation markers. - The correlation between patients amount of body fat and platelet activity. - Change of the platelet activity, inflammation markers and lipid profile in time after beginning of treatment. ;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated at the end of the study. | — |
Countries
Austria
Contacts
Public ContactATVB
Verein zur Fördferung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB)
Outcome results
None listed