EVOLOCUMAB for Atherosclerotic cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Male or female patient, aged 40 to 85\n- More than 50 kilograms\n- LDL-C level ≥ 0.7 g / L (biological assessment of less than 6 months)\n- For which coronarography is indicated according to European guidelines\n- Affiliated with social security\n- Signed informed consent form"}

Exclusion criteria

• {"criterion_text":"- Clinical presentation of unstable angina\n- Actual use of PCSK9 inhibitior (evolocumab or others)\n- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN at screening\n- LDL apheresis within 12 months prior to randomization\n- Active infection or others active disease judge by investigator incompatible with the protocole completion\n- Known sensitivity to evolocumab or their excipients to be administered during dosing or natural rubber / latex\n- Patient likely to not be available to complete all protocol-required study visits or procedures.\n- Patient in exclusion period of another study\n- Woman able to procreate in the absence of highly effective contraception\n- Persons referred to in Articles L1121-6 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)\n- Patient whose state of physical or psychological health could compromise the obtaining of his informed consent and his compliance with the requirements of the protocol, with the study evaluation, procedures or completion.\n- End stage disease (estimated survival of less than one year)\n- Severe renal dysfunction, defined as an estimated creatinine clearance (MDRD) < 30 mL/min at screening\n- Contra-indication to adenosin : hypersensitivity to active active substance or to any of the excipients, type II or III atrioventricular block or atrial disease (except for pacemaker users), long QT syndrome, severe arterial hypotension, acute heart failure, asthma and severe chronic obstructive pulmonary disease, unstable angina unstabilized by drug therapy, taking dipyridamole, aminophylline, theophylline or other xanthine base within 24 hours prior to adenosine administration\n- Contra-indication to heparin: hypersensitivity to active substance or to any of the excipients, past heparin induced thrombopenia type II, haemorrhage.\n- Prior CABG\n- Prior myocardial infarction in the territory needing coronary microcirculation measurement\n- NYHA class III or IV, or last known left ventricular ejection fraction < 30%"}

Primary endpoints

• {"endpoint_text":"- Index of microcirculatory resistance (IMR), measured during invasive coronary angiography (ICA) (in mmHg.s).","definition_or_measurement_approach":"IMR measured during coronary angiography, defined by the product of the distal coronary pressure by the mean transit time of 3 ml of room-temperature saline during hyperemia induced by adenosine, expressed in mm Hg.s."}

Secondary endpoints

• {"endpoint_text":"- Troponin I level after PCI.\n- Coronary angiography parameters and coronary physiology: % epicardial stenosis, FFR, CFR, IMR\n- Resting ultrasound parameters: systolic and diastolic function, myocardial deformation.","definition_or_measurement_approach":"Troponin I measured after PCI (laboratory assay); coronary angiography and physiology parameters measured by standard angiographic and invasive physiology assessments (percent epicardial stenosis, FFR, CFR, IMR); resting echocardiography parameters assessing systolic and diastolic function and myocardial deformation."}

France

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

15-11-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

66

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Federation of Cardiology","duties_or_roles":"Monetary support","organisation_type":""}