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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
First received
Last updated
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
Health authority
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Status Withdrawn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).

Study Design


Related Conditions & MeSH terms


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
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