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

Phase 2

Withdrawn

• Conditions: ST-elevation Myocardial Infarction
• Interventions: Biological: Evolocumab

• Registration Number: NCT04303377
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Timeline

• Study Start: 2019-11-18
• Primary Completion: 2020-01-02
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-11
• Study Completion: 2020-07-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evolocumab	Evolocumab	Evolocumab administration in the acute phase of ST elevation myocardial infarction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, PV, Italy