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Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction (ExOTIC)

Primary Purpose

ST-elevation Myocardial Infarction

Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Evolocumab
Sponsored by
Foundation IRCCS San Matteo Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Evolocumab

Standard of care

Arm Description

Evolocumab administration in the acute phase of ST elevation myocardial infarction

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Inflammatory Cytokine Response
Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor
Cholesterol LDL levels
Absolute and percentage changes in c-LDL levels
Major adverse cardiovascular events
Rate of composite cardiovascular death, MI or stroke
Euroqol 5-dimension questionnaire
Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)

Full Information

First Posted
March 6, 2020
Last Updated
April 22, 2021
Sponsor
Foundation IRCCS San Matteo Hospital
Collaborators
Centro Cardiologico Monzino, Ospedale Bassini Cinisello Balsamo, Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Policlinico San Martino, Fondazione Poliambulanza Istituto Ospedaliero, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliera Sant'Anna e San Sebastiano, Azienda Ospedaliera, Ospedale Civile di Legnano
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1. Study Identification

Unique Protocol Identification Number
NCT04303377
Brief Title
Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
Acronym
ExOTIC
Official Title
Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor required early termination of the economic agreement due to a supposed extension of the enrollment period for bureaucracy reasons and for the concomitant Covid -19 Pandemic
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
July 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation IRCCS San Matteo Hospital
Collaborators
Centro Cardiologico Monzino, Ospedale Bassini Cinisello Balsamo, Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Policlinico San Martino, Fondazione Poliambulanza Istituto Ospedaliero, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliera Sant'Anna e San Sebastiano, Azienda Ospedaliera, Ospedale Civile di Legnano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Evolocumab administration in the acute phase of ST elevation myocardial infarction
Arm Title
Standard of care
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
Repatha
Intervention Description
Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)
Primary Outcome Measure Information:
Title
Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI
Description
• Myocardial salvage index (MSI) at 6 months evaluated with cardiac magnetic resonance (CMR)
Time Frame
6 months Visit
Secondary Outcome Measure Information:
Title
Inflammatory Cytokine Response
Description
Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor
Time Frame
6 months Visit
Title
Cholesterol LDL levels
Description
Absolute and percentage changes in c-LDL levels
Time Frame
6 months Visit
Title
Major adverse cardiovascular events
Description
Rate of composite cardiovascular death, MI or stroke
Time Frame
12 months Visit
Title
Euroqol 5-dimension questionnaire
Description
Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)
Time Frame
12 months Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction

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