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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Withdrawn; Phase 2

Conditions: ST-elevation Myocardial Infarction

Treatments: Biological: Evolocumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04303377

EXO_01

2018-001065-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Evolocumab

Experimental group

Description:

Evolocumab administration in the acute phase of ST elevation myocardial infarction

Treatment:

Biological: Evolocumab

Standard of care

No Intervention group