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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04303377

Acronym

ExOTIC

Enrollment

Registered

2020-03-11

Start date

2019-11-18

Completion date

2020-07-24

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-elevation Myocardial Infarction

Keywords

Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance

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.

Interventions

BIOLOGICALEvolocumab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026