Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 26, 2021

Keywords

ClinConnect Summary

This clinical trial, called AMUNDSEN-real, is studying whether a medication called evolocumab can more effectively lower cholesterol levels in patients who have recently experienced a heart attack, known as STEMI or NSTEMI. The goal is to see if evolocumab can reduce a specific type of cholesterol (LDL-C) by at least 50% and help patients reach a target level of less than 1.4 mmol/L within 12 months. Participants in the trial will be randomly assigned to receive either evolocumab or standard treatments typically used for managing cholesterol after a heart attack.

To be eligible for the trial, participants must be at least 55 years old and have a confirmed diagnosis of STEMI or NSTEMI. They should also be on a maximum tolerated dose of a cholesterol-lowering medication called a statin at the time of enrollment. Participants can expect to be monitored closely throughout the study, as their progress will be tracked for a year to see how well their cholesterol levels respond to treatment. It's important to know that certain conditions, such as ongoing serious health issues or recent treatments, may prevent someone from participating in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participant meeting all of the following criteria will be considered for enrolment into the trial:
• • 1. Male or female
• • 2. Diagnosis of STEMI or NSTEMI
• STEMI defined as:
• • symptoms of acute MI of at least 30 min AND
• • within the previous 24 hours with new persistent ST-segment elevation ≥1 mm in ≥2 continuous ECG leads AND
• • an indication for primary PCI AND
• • \> 55 years reported by the patient
• NSTEMI defined as:
• • Age≥18
• • a history of chest discomfort or ischemic symptoms of ≥10 minutes duration at rest ≤48 hours prior to entry into the trial with no evidence of persistent ST-segment elevation and with an elevated troponin (≥ the upper limit of normal according to local laboratory norms), AND
• • indication for a coronary angiogram within 72hrs AND
• • indication for PCI AND
• • 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
• • 3. Statin at maximal tolerated dose, as part of the standard of care at randomization, means Intent to treat with statin and the patient will receive his first dose as soon as possible after admission
• • 4. Informed consent obtained in writing at enrolment into the trial
• Exclusion Criteria:
• Participant presenting with any of the following will not be included in the trial:
• • 1. Fibrinolysis treatment
• • 2. Planned CABG
• 3. Ongoing hemodynamic instability defined as any of the following:
• • Killip Class III or IV
• • Sustained and/or symptomatic hypotension (systolic blood pressure \< 80 mm Hg)
• • Known left ventricular ejection fraction \< 30%
• • 4. Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
• • 5. Active malignancy
• • 6. A comorbid condition with an estimated life expectancy of ≤ 12 months
• • 7. Previously received or receiving evolocumab or any other therapy to inhibit PCSK9
• • 8. Known sensitivity to any of the products or components to be administered during trial
• • 9. 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
• • 10. Currently receiving treatment in any other investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial.
• • 11. Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.