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

Sponsor

Foundation IRCCS San Matteo Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04303377

Collaborator

Centro Cardiologico Monzino (Other), Ospedale Bassini Cinisello Balsamo (Other), Azienda Ospedaliera Ordine Mauriziano di Torino (Other), Ospedale Policlinico San Martino (Other), Fondazione Poliambulanza Istituto Ospedaliero (Other), Azienda Ospedaliera San Gerardo di Monza (Other), Azienda Ospedaliera Sant'Anna e San Sebastiano (Other), Azienda Ospedaliera, Ospedale Civile di Legnano (Other)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ST-elevation Myocardial Infarction	Biological: Evolocumab	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2019

Actual Primary Completion Date :

Jan 2, 2020

Actual Study Completion Date :

Jul 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evolocumab Evolocumab administration in the acute phase of ST elevation myocardial infarction	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
No Intervention: Standard of care

Arm

Intervention/Treatment

Experimental: Evolocumab

Evolocumab administration in the acute phase of ST elevation myocardial infarction

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

No Intervention: Standard of care

Outcome Measures

Primary Outcome Measures

Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI [6 months Visit]
• Myocardial salvage index (MSI) at 6 months evaluated with cardiac magnetic resonance (CMR)

Secondary Outcome Measures

Inflammatory Cytokine Response [6 months Visit]
Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor
Cholesterol LDL levels [6 months Visit]
Absolute and percentage changes in c-LDL levels
Major adverse cardiovascular events [12 months Visit]
Rate of composite cardiovascular death, MI or stroke
Euroqol 5-dimension questionnaire [12 months Visit]
Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Matteo	Pavia	PV	Italy	27100

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marco Ferlini, Principal Investigator, Foundation IRCCS San Matteo Hospital

ClinicalTrials.gov Identifier:

NCT04303377

Other Study ID Numbers:

EXO_01
2018-001065-17

First Posted:

Mar 11, 2020

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Marco Ferlini, Principal Investigator, Foundation IRCCS San Matteo Hospital

Myocardial Infarction

Percutaneous Coronary Intervention

Evolocumab

Cardiac Magnetic Resonance

Additional relevant MeSH terms: