Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction

NCT ID: NCT04303377

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2020-07-24

Brief Summary

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.

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.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evolocumab

Evolocumab administration in the acute phase of ST elevation myocardial infarction

Group Type: EXPERIMENTAL

Evolocumab

Intervention Type: BIOLOGICAL

Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Evolocumab

Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)

Intervention Type: BIOLOGICAL

Other Intervention Names

Repatha

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: collaborator

Ospedale Bassini Cinisello Balsamo

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role: collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role: collaborator

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Sant'Anna e San Sebastiano

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera, Ospedale Civile di Legnano

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Marco Ferlini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Policlinico San Matteo

Pavia, PV, Italy

Countries

Italy

Other Identifiers

2018-001065-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EXO_01

Identifier Type: -

Identifier Source: org_study_id