Acute myocardial infarction leading to percutaneous coronary angioplasty MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: EVOLOCUMAB
Product Name: Evolocumab (Repatha®) 140 mg
Product Code: [C10AX13]
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Evolocumab
CAS Number: 1256
Sponsors
ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female - Diagnosis of STEMI defined as: o symptoms of acute MI of at least 30 min AND o within the previous 24 hours with new persistent ST-segment elevation =1 mm in =2 continuous ECG leads AND o an indication for primary PCI AND o > 55 years or - Diagnosis of NSTEMI defined as o a history of chest discomfort or ischemic symptoms of =10 minutes duration at rest =48 hours prior to entry into the study with no evidence of persistent ST-segment elevation and with an elevated troponin (= the upper limit of normal according to local laboratory norms), AND o indication for a coronary angiogram within 72hrs AND o indication for PCI AND o at least one the following high-risk characteristics: • Diabetes • Peripheral Artery Disease • Multivessel (= 2 or LM) disease on the coronary angiogram • History of MI or stroke without sequels prior to randomization • eGFR: 15 to 45 mL/min/1.73 m2 calculated with MDRD formula at randomization - Informed consent obtained in writing at enrolment into 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 668 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 998
Exclusion criteria
Exclusion criteria: Participant presenting with any of the following will not be included in the study: - Fibrinolysis treatment - Planned CABG - Ongoing hemodynamic instability defined as any of the following: o Killip Class III or IV o Sustained and/or symptomatic hypotension (systolic blood pressure < 80 mm Hg) o Known left ventricular ejection fraction < 30% - Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis - Active malignancy - A comorbid condition with an estimated life expectancy of = 12 months - Previously received or receiving evolocumab or any other therapy to inhibit PCSK9 - Known sensitivity to any of the products or components to be administered during study - Female subject is pregnant, had a positive pregnancy test at inclusion, breastfeeding, or planning to become pregnant or breastfeed during treatment and for an additional 17 weeks after the last dose of IMP - Currently receiving treatment in any other investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). - Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator’s knowledge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of = 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL), at 12 months follow-up, in the overall population.;Secondary Objective: The secondary objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of = 50% from baseline and a LDL-C goal of <1.4 mmol/L (<55 mg/dL), at 12 months follow-up, country per country;Primary end point(s): The primary endpoint is the LDL-C reduction of = 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up. This endpoint will consider the LDL-C levels measured at the time of randomization for baseline and at the final 12-months follow-up visit.;Timepoint(s) of evaluation of this end point: Follow-up visits including LDL-C measurement will be performed at 6, 22 weeks and 12 months after randomization. At 38 weeks, if LDL-C measurement is available, the data will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is LDL-C reduction of = 50% from baseline and a final LDL-C of <1.4 mmol/L (<55 mg/dL) at 12 months follow-up, country by country. The same rules as above for the primary endpoint, will apply. Other secondary endpoints of lipids control: • LDL-C reduction of = 50% from baseline and an LDL-C goal of <1.4 mmol/L (<55 mg/dL) at 6 and 22 weeks, • Percent change in levels of LDL-C from baseline to 6, 22 weeks and 12 months, • Time to achieve LDL-C target, • Time averaged LDL-C change over 12 months, • Change from baseline on other lipid parameters (total cholesterol, HDL-C, triglycerides, non-HDL-C) at 6, 22 weeks and 12 months.;Timepoint(s) of evaluation of this end point: The same rules as above for the primary evaluation criterion will be applied. | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain, Switzerland
Contacts
Public ContactDamien VANHOYE
APHP
Outcome results
None listed