Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world- The AMUNDSEN-real study

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-000573-80-FR
• Lead Sponsor: APHP DRCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-10
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male or female
-Diagnosis of STEMI defined as:
osymptoms of acute MI of at least 30 min AND
owithin the previous 24 hours with new persistent ST-segment elevation =1 mm in =2 continuous ECG leads AND
oan indication for primary PCI AND
o> 55 years
or
-Diagnosis of NSTEMI defined as
oa 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
oindication for a coronary angiogram within 72hrs AND
oindication 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
oKillip Class III or IV
oSustained and/or symptomatic hypotension (systolic blood pressure < 80 mm Hg)
oKnown 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified