ST-elevation Myocardial Infarction Clinical Trial
— ExOTICOfficial title:
Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
Verified date | April 2021 |
Source | Foundation IRCCS San Matteo Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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). |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico San Matteo | Pavia | PV |
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 |
Italy,
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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