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

NCT04951856 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: APHP2010752021-000573-80
• Study Type: interventional
• Target: 2,166
• Locations: 1 country
• Sites: 1

Brief Summary

AMUNDSEN-real is a phase IV, international (7 European countries), multicenter, controlled, open label study randomized, in 2 parallel groups of patients with a diagnosis of STEMI or NSTEMI with an indication for PCI, using the PROBE study design (Prospective Randomised Open, Blinded Endpoint). The 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 on the overall population. The primary clinical objective is to demonstrate the superiority of evolocumab versus standard of care on the composite endpoint of death or any unplanned hospitalization for a CV reason at 12 months. Central randomization uses an IWRS. Stratification is by center and stratum with random block size, generated according to the procedures of the sponsor, by a statistician not involved in the study.

Conditions

STEMI - ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation MI

Keywords

STEMI; NSTEMI; PCI; STATIN; EVOLOCUMAB; Anti-PCSK9; LDL-C

Outcome Measures

Primary Outcomes (2)

• 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

  Monitoring of changes in LDL-C levels

  From baseline and at 12 months

• Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason

  Main clinical endpoint obtained from reported adverse events occurred during participation to the study

  Frome randomization to 12 months follow-up

Secondary Outcomes (6)

• LDL-C<40mg/dL at 12 months follow-up

  from baseline and at 12 months follow-up

• Composite of death (any cause), MI, stroke, unplanned revascularization

  from randomization to 12 months follow-up

• Composite of death (any cause), MI, stroke

  from randomization to 12 months follow-up

• Composite of death (any cause) or myocardial infarction

  from randomization to 12 months follow-up

• Death (any cause)

  from randomization to 12 months follow-up

Other Outcomes (19)

• 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.

  From baseline and at 12 months

• LDL-C reduction of ≥ 50% and an LDL-C goal of <1.4 mmol/L (<55 mg/dL) in the overall population

  From baseline and end-of-follow-up (longest follow up for each patient, up to 3 years)

• Composite endpoint of death or any hospitalization for a Cardiovascular (CV) reason

  At longest follow-up for each patient, up to 3 years

Study Arms (2)

Evolocumab + SOC

EXPERIMENTAL

Investigational Product is open label Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 36 months.

Drug: Evolocumab 140 MG/ML

Standard of care (SOC)

ACTIVE COMPARATOR

management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria

Drug: Standard of care (SOC)

Interventions

Evolocumab 140 MG/ML DRUG

Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 36 months.

Also known as: Repatha

Evolocumab + SOC

Standard of care (SOC) DRUG

management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria

Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant meeting all of the following criteria will be considered for enrolment into the trial:
• 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
• 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
• Informed consent obtained in writing at enrolment into the trial

You may not qualify if:

• Participant presenting with any of the following will not be included in the trial:
• Fibrinolysis treatment
• Planned CABG
• 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%
• 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 trial
• 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.
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Action Research Group: collaborator
• Amgen: collaborator

Study Sites (1)

ACTION Group, Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC

Paris, 75013, France

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

evolocumab; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gilles MONTALESCOT, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: July 7, 2021
• Study Start: September 29, 2021
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): May 22, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)