Clinical trial NCT04303377: Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
Official title: Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: ST-elevation Myocardial Infarction
Keywords: Myocardial Infarction
Percutaneous Coronary Intervention
Evolocumab
Cardiac Magnetic Resonance
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: Ospedale Bassini Cinisello Balsamo
name: Azienda Ospedaliera Ordine Mauriziano di Torino
name: Ospedale Policlinico San Martino
name: Fondazione Poliambulanza Istituto Ospedaliero
name: Azienda Ospedaliera San Gerardo di Monza
name: Azienda Ospedaliera Sant'Anna e San Sebastiano
name: Azienda Ospedaliera, Ospedale Civile di Legnano
First posted: 2020-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI
timeFrame: 6 months Visit
Secondary outcomes:
measure: Inflammatory Cytokine Response
timeFrame: 6 months Visit
measure: Cholesterol LDL levels
timeFrame: 6 months Visit
measure: Major adverse cardiovascular events
timeFrame: 12 months Visit
measure: Euroqol 5-dimension questionnaire
timeFrame: 12 months Visit
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: PV
Study officials:
References: