Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to… (NCT04951856) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
France2,166 participantsStarted 2021-09-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of STEMI or NSTEMI
✓. 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
Exclusion criteria
✕. Fibrinolysis treatment
✕. Planned CABG
✕. Ongoing hemodynamic instability defined as any of the following:
✕. 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
What they're measuring
1
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
Timeframe: From baseline and at 12 months
2
Composite endpoint of death (any cause) or any unplanned hospitalization for a CV reason
Timeframe: Frome randomization to 12 months follow-up