ST Elevation Myocardial InfarctionPhase 2REAL-TIMI 63BNCT03578809
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
A Phase 2 study testing MEDI6012 in people with ST Elevation Myocardial Infarction, run by MedImmune LLC at 37 sites in 10 countries.
Trial summary
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- MEDI6012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 593 participants
- Where
- 37 sitesin 10 countries
- Study dates
- 5 Jun 2018to 18 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- Planned for primary PCI (percutaneous coronary intervention)
- Men and women without child-bearing potential aged 30-80 years of age
- Capable and willing to provide informed consent.
- Capable of completing study visits
Who cannot join
- Fibrinolytic administration for index event
- Known prior MI or prior coronary artery bypass graft (CABG) surgery
- Known pre-existing cardiomyopathy
- History of anaphylaxis
- Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
Czechia7 sites
Research Site
Brno, 65691
Research Site
Hradec Králové, 500 05
Research Site
Liberec, 46063
Research Site
Pardubice, 53203
Research Site
Prague, 10034
Research Site
Prague, 12808
Research Site
Ústí nad Labem, 40113
Israel7 sites
Research Site
Beersheba, 8410101
Research Site
Haifa, 3109601
Research Site
Jerusalem, 9103102
Research Site
Jerusalem, 91120
Research Site
Petah Tikva, 4941492
Research Site
Ramat Gan, 5265601
Research Site
Tel Aviv, 6423906
Brazil4 sites
Research Site
Belo Horizonte, 30110-934
Research Site
Campinas, 13060-080
Research Site
Porto Alegre, 90610-000
Research Site
Porto Alegre, 90620-001
Netherlands3 sites
Research Site
Alkmaar, 1815 JD
Research Site
Nijmegen, 6525 GA
Research Site
Nijmegen, 6532 SZ
Poland3 sites
Research Site
Bydgoszcz, 85-094
Research Site
Lodz, 90-549
Research Site
Lodz, 91-347
Russia3 sites
Research Site
Kazan', 420101
Research Site
Saint Petersburg, 197044
Research Site
Saint Petersburg, 197706
Spain3 sites
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Pontevedra, 36312
United Kingdom3 sites
Research Site
Dundee, DD1 9SY
Research Site
Leeds, LS13EX
Research Site
Stevenage, SG1 4AB
Slovakia2 sites
Research Site
Banská Bystrica, 974 01
Research Site
Nitra, 949 01
About this study
Official title: A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- MEDI6012, Placebo
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI6012Biological
Also called MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push.
MEDI6012
PlaceboOther
Also called Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B.
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Placebo | Placebo comparator | Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push. Receives: Other: Placebo |
| Cohort A: MEDI6012 | Experimental | Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push. Receives: Biological: MEDI6012 |
| Cohort B: Placebo | Placebo comparator | Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push. Receives: Other: Placebo |
| Cohort B: MEDI6012 | Experimental | Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push. Receives: Biological: MEDI6012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Infarct Size
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
Measured: 70 to 84 days post Day 1 dose
Secondary outcomes (9)
Left Ventricular Ejection Fraction (LVEF)
The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported.
Measured: 70 to 84 days post Day 1 dose
Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B
Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI is reported. The index CTA was preferably to be performed between 48 to 72 hours post Dose 1 (could be done up to 5 days post Dose 1) but no earlier than 40 hours post Dose 1. Participants with creatinine clearance >= 60 mL/min (Cockcroft Gault equation) within 6 hours underwent an index coronary CTA no earlier than 40 hours following the first dose.
Measured: Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
Left Ventricular Mass by Late Gadolinium Enhancement (LGE)
The left ventricular mass by LGE is reported.
Measured: 70 to 84 days post Day 1 dose
Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)
The left ventricular mass by cine MRI is reported.
Measured: 70 to 84 days post Day 1 dose
Left Ventricular End-diastolic and End-systolic Volume
Left ventricular end-diastolic and end-systolic volume is reported.
Measured: 70 to 84 days post Day 1 dose
Left Ventricular End-diastolic and End-systolic Volume Index
Left ventricular end-diastolic and end-systolic volume index is reported.
Measured: 70 to 84 days post Day 1 dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: Day 1 through Day 195 post Day 1 dose
Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)
Serum concentration of MEDI6012 is reported.
Measured: Pre- and post-dose on Days 1, 3, 17, and 31
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012
Number of participants with positive ADA titer to MEDI6012 are reported in 3 categories, ADA positive at any visit up to Day 70-84 follow-up visit, ADA positive with > 30% decrease in HDL-C from baseline (on the same date) at any visit up to D70-84 FU V, and ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit.
Measured: Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start5 Jun 2018
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The TIMI Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578809
- Sponsor's protocol ID
- D5780C00007
- Acronym
- REAL-TIMI 63B
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2018
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Bonaca MP, Morrow DA, Bergmark BA, Berg DD, Lima JAC, Hoffmann U, Kato Y, Lu MT, Kuder J, Murphy SA, Spinar J, Oude Ophuis T, Kiss RG, Lopez-Sendon J, Averkov O, Wheatcroft SB, Kubica J, Carlos Nicolau J, Furtado RHM, Abuhatzira L, Hirshberg B, Omar SA, Vavere AL, Chang YT, George RT, Sabatine MS. Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B. Circulation. 2022 Sep 20;146(12):907-916. doi: 10.1161/CIRCULATIONAHA.122.059325. Epub 2022 Aug 30.
PubMed 36039762
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03578809
- Acronym / sponsor ID
- REAL-TIMI 63B / D5780C00007
- Conditions
- ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- The TIMI Study Group
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 9 Feb 2022
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 Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push. |
| Cohort A: MEDI6012 | Experimental | Biological: MEDI6012Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push. |
| Cohort B: Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push. |
| Cohort B: MEDI6012 | Experimental | Biological: MEDI6012Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
- Planned for primary PCI (percutaneous coronary intervention)
- Men and women without child-bearing potential aged 30-80 years of age
- Capable and willing to provide informed consent.
- Capable of completing study visits
Key exclusion criteria (5 listed)
- Fibrinolytic administration for index event
- Known prior MI or prior coronary artery bypass graft (CABG) surgery
- Known pre-existing cardiomyopathy
- History of anaphylaxis
- Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
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 |
|---|---|---|
| MEDI6012Also: MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push.MEDI6012 | Biological | Cohort A: MEDI6012, Cohort B: MEDI6012 |
| PlaceboAlso: Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B.Placebo | Other | Cohort A: Placebo, Cohort B: Placebo |
Primary outcome
Global Infarct Size
Time frame: 70 to 84 days post Day 1 dose
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
9 secondary outcomes
Left Ventricular Ejection Fraction (LVEF)
Time frame: 70 to 84 days post Day 1 dose
Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B
Time frame: Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
Left Ventricular Mass by Late Gadolinium Enhancement (LGE)
Time frame: 70 to 84 days post Day 1 dose
Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)
Time frame: 70 to 84 days post Day 1 dose
Left Ventricular End-diastolic and End-systolic Volume
Time frame: 70 to 84 days post Day 1 dose
Left Ventricular End-diastolic and End-systolic Volume Index
Time frame: 70 to 84 days post Day 1 dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through Day 195 post Day 1 dose
Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)
Time frame: Pre- and post-dose on Days 1, 3, 17, and 31
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012
Time frame: Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36039762Bonaca MP, Morrow DA, Bergmark BA, Berg DD, Lima JAC, Hoffmann U, Kato Y, Lu MT, Kuder J, Murphy SA, Spinar J, Oude Ophuis T, Kiss RG, Lopez-Sendon J, Averkov O, Wheatcroft SB, Kubica J, Carlos Nicolau J, Furtado RHM, Abuhatzira L, Hirshberg B, Omar SA, Vavere AL, Chang YT, George RT, Sabatine MS. Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B. Circulation. 2022 Sep 20;146(12):907-916. doi: 10.1161/CIRCULATIONAHA.122.059325. Epub 2022 Aug 30.
- D5780C00007 CSP RedactedLink provided by the sponsor.
- D5780C00007 SAP RedactedLink provided by the sponsor.
- D5780C00007 CSR Synopsis RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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ST Elevation Myocardial Infarction
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.
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI6012 in people with ST Elevation Myocardial Infarction, run by MedImmune LLC at 37 sites in 10 countries.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Czechia, Israel, Brazil, Netherlands, Poland and 5 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Infarct Size (time frame: 70 to 84 days post Day 1 dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578809, which also lists 1 linked publication.
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 9 Feb 2022.