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

ST-elevation Myocardial Infarction Clinical Trial

— ExOTIC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04303377
• Other study ID #: EXO_01
• Secondary ID: 2018-001065-17
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 18, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: April 2021
• Source: Foundation IRCCS San Matteo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia	PV

Sponsors (9)

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

Country where clinical trial is conducted

Italy, 

Outcome

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