Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction (ExOTIC)

Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)

This is a prospective, multi-centre, open label, randomised study of Phase II that enrolls patients hospitalized with a diagnosis of ST-elevation myocardial infarction (STEMI), comparing Evolocumab versus Standard of Care.

Study Overview

• Status: Withdrawn
• Conditions: ST-elevation Myocardial Infarction
• Intervention / Treatment: Biological: Evolocumab

Detailed Description

Primary objective of the study is to assess whether early evolocumab administration reduces infarct size in patients with STEMI undergoing primary PCI.

At least 150 patients will be enrolled to investigate the efficacy and safety of evolocumab administration in the acute phase of STEMI.

Patients will be followed for 1 year after the enrollment.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Chest pain or equivalent lasting > 20 minutes
• ST elevation myocardial infarction scheduled for primary PCI
• Signed written informed consent

Exclusion Criteria:

• Previous myocardial infarction
• Previous percutaneous or surgical myocardial revascularization
• Ongoing treatment with any statin or ezetimibe
• History of congestive heart failure
• Cardiogenic shock at presentation
• Known Pregnancy
• Women of Childbearing Age
• Known major active infection or major hematologic, renal, hepatic, or endocrine dysfunction
• Malignancy (except non-melanoma skin cancer, cervical in situ carcinoma, breast ductal carcinoma in situ, stage 1 prostate carcinoma) within the last 10 years
• Patients with hypersensitivity to the active substance (evolocumab) or to any of its excipients
• Inability to attend the scheduled clinical evaluation and laboratory tests
• Inability to undergo the pharmacological treatment or other procedures of the study
• Currently enrolled in another investigational drug study, or < 30 days/<5 half-life since ending another investigational drug study(s).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of care
EXPERIMENTAL: Evolocumab; Evolocumab administration in the acute phase of ST elevation myocardial infarction	Biological: Evolocumab; Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe); Other Names: Repatha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI	• Myocardial salvage index (MSI) at 6 months evaluated with cardiac magnetic resonance (CMR)	6 months Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Cytokine Response	Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor	6 months Visit
Cholesterol LDL levels	Absolute and percentage changes in c-LDL levels	6 months Visit
Major adverse cardiovascular events	Rate of composite cardiovascular death, MI or stroke	12 months Visit
Euroqol 5-dimension questionnaire	Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)	12 months Visit

Collaborators and Investigators

• Sponsor: Foundation IRCCS San Matteo Hospital
• Collaborators: Fondazione Poliambulanza Istituto Ospedaliero; Azienda Ospedaliera Ordine Mauriziano di Torino; Azienda Ospedaliera San Gerardo di Monza; Centro Cardiologico Monzino; Ospedale Policlinico San Martino; Azienda Ospedaliera, Ospedale Civile di Legnano; Azienda Ospedaliera Sant'Anna e San Sebastiano; Ospedale Bassini Cinisello Balsamo

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2019
• Primary Completion (ACTUAL): January 2, 2020
• Study Completion (ACTUAL): July 24, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Myocardial Infarction; Cardiac Magnetic Resonance; Evolocumab
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evolocumab
• Other Study ID Numbers: EXO_01; 2018-001065-17 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes