ST-elevation Myocardial InfarctionPhase 2ExOTICNCT04303377
Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
A Phase 2 study testing Evolocumab in people with ST-elevation Myocardial Infarction, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Evolocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 18 Nov 2019to 24 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Chest pain or equivalent lasting > 20 minutes
- ST elevation myocardial infarction scheduled for primary PCI
- Signed written informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
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.
Read the 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.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Evolocumab
- Keywords
- Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabBiological
Also called Repatha
Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | Evolocumab administration in the acute phase of ST elevation myocardial infarction Receives: Biological: Evolocumab |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months Visit
Secondary outcomes (4)
Inflammatory Cytokine Response
Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor
Measured: 6 months Visit
Cholesterol LDL levels
Absolute and percentage changes in c-LDL levels
Measured: 6 months Visit
Major adverse cardiovascular events
Rate of composite cardiovascular death, MI or stroke
Measured: 12 months Visit
Euroqol 5-dimension questionnaire
Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)
Measured: 12 months Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start18 Nov 2019
- Primary completion2 Jan 2020
- Study completion24 Jul 2020
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Marco Ferlini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303377
- Sponsor's protocol ID
- EXO_01
- Other IDs
- 2018-001065-17, 2018
- Acronym
- ExOTIC
- Status last verified
- Nov 2024
- First submitted
- 6 Mar 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
- ClinicalTrials.gov ID
- NCT04303377
- Acronym / sponsor ID
- ExOTIC / EXO_01
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- 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
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Biological: EvolocumabEvolocumab administration in the acute phase of ST elevation myocardial infarction |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Chest pain or equivalent lasting > 20 minutes
- ST elevation myocardial infarction scheduled for primary PCI
- Signed written informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: RepathaEvolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe) | Biological | Evolocumab |
Primary outcome
Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI
Time frame: 6 months Visit
• Myocardial salvage index (MSI) at 6 months evaluated with cardiac magnetic resonance (CMR)
4 secondary outcomes
Inflammatory Cytokine Response
Time frame: 6 months Visit
Cholesterol LDL levels
Time frame: 6 months Visit
Major adverse cardiovascular events
Time frame: 12 months Visit
Euroqol 5-dimension questionnaire
Time frame: 12 months Visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evolocumab in people with ST-elevation Myocardial Infarction, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI (time frame: 6 months Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.