NCT04303377

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2020

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

March 6, 2020

Last Update Submit

November 20, 2024

Conditions

ST-elevation Myocardial Infarction

Keywords

Myocardial InfarctionPercutaneous Coronary InterventionEvolocumabCardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Inflammatory Cytokine Response

    6 months Visit

  • Cholesterol LDL levels

    6 months Visit

  • Major adverse cardiovascular events

    12 months Visit

  • Euroqol 5-dimension questionnaire

    12 months Visit

Study Arms (2)

Evolocumab

EXPERIMENTAL

Evolocumab administration in the acute phase of ST elevation myocardial infarction

Biological: Evolocumab

Standard of care

NO INTERVENTION

Interventions

EvolocumabBIOLOGICAL

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

Also known as: Repatha
Evolocumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • Chest pain or equivalent lasting \> 20 minutes
  • ST elevation myocardial infarction scheduled for primary PCI
  • Signed written informed consent

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 11, 2020

Study Start

November 18, 2019

Primary Completion

January 2, 2020

Study Completion

July 24, 2020

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

IT(1)