Status:
WITHDRAWN
Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Centro Cardiologico Monzino
Ospedale Bassini Cinisello Balsamo
Conditions:
ST-elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ve...
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 inves...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Chest pain or equivalent lasting \> 20 minutes
- ST elevation myocardial infarction scheduled for primary PCI
- Signed written informed consent
Exclusion
- 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).
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04303377
Start Date
November 18 2019
End Date
July 24 2020
Last Update
November 21 2024
Active Locations (1)
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1
IRCCS Policlinico San Matteo
Pavia, PV, Italy, 27100