Trial | NCT04303377  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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.
Study Started
Nov 18
2019
Primary Completion
Jan 02
2020
Study Completion
Jul 24
2020
Last Update
Apr 26
2021

Biological Evolocumab

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

  • Other names: Repatha

Evolocumab Experimental

Evolocumab administration in the acute phase of ST elevation myocardial infarction

Standard of care No Intervention

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).
No Results Posted