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| Name | Class |
|---|---|
| The TIMI Study Group | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI6012 | Biological | MEDI6012 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 70 to 84 days post Day 1 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported. | 70 to 84 days post Day 1 dose |
| Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Belo Horizonte | 30110-934 | Brazil | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36039762 | Derived | 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. |
| Label | URL |
|---|---|
| D5780C00007 CSP Redacted | View source |
Not provided
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
In total, 593 participants were randomized into the study and 575 participants were treated with the study drug.
This study was conducted in 10 countries (Brazil, Czech Republic, Hungary, Israel, Netherlands, Poland, Russian Federation, Slovakia, Spain, and the United Kingdom).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Placebo | Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push. |
| FG001 | Cohort A: MEDI6012 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2020 | Jan 13, 2022 |
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In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
| Placebo | Other | Placebo |
|
|
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. |
| 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. | 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. | 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. | 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. | 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. | Day 1 through Day 195 post Day 1 dose |
| Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Serum concentration of MEDI6012 is reported. | 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. | Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose |
| Campinas |
| 13060-080 |
| Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 90620-001 | Brazil |
| Research Site | Brno | 65691 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Liberec | 46063 | Czechia |
| Research Site | Pardubice | 53203 | Czechia |
| Research Site | Prague | 10034 | Czechia |
| Research Site | Prague | 12808 | Czechia |
| Research Site | Ústí nad Labem | 40113 | Czechia |
| Research Site | Budapest | 1122 | Hungary |
| Research Site | Budapest | 1134 | Hungary |
| Research Site | Beersheba | 8410101 | Israel |
| Research Site | Haifa | 3109601 | Israel |
| Research Site | Jerusalem | 9103102 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Petah Tikva | 4941492 | Israel |
| Research Site | Ramat Gan | 5265601 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Alkmaar | 1815 JD | Netherlands |
| Research Site | Nijmegen | 6525 GA | Netherlands |
| Research Site | Nijmegen | 6532 SZ | Netherlands |
| Research Site | Bydgoszcz | 85-094 | Poland |
| Research Site | Lodz | 90-549 | Poland |
| Research Site | Lodz | 91-347 | Poland |
| Research Site | Kazan' | 420101 | Russia |
| Research Site | Saint Petersburg | 197044 | Russia |
| Research Site | Saint Petersburg | 197706 | Russia |
| Research Site | Banská Bystrica | 974 01 | Slovakia |
| Research Site | Nitra | 949 01 | Slovakia |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Pontevedra | 36312 | Spain |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | Leeds | LS13EX | United Kingdom |
| Research Site | Stevenage | SG1 4AB | United Kingdom |
| D5780C00007 SAP Redacted | View source |
| D5780C00007 CSR Synopsis Redacted | View source |
Participants received 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. |
| FG002 | Cohort B: Placebo | Participants received 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. |
| FG003 | Cohort B: MEDI6012 | Participants received 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. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants, grouped according to assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Placebo | Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push. |
| BG001 | Cohort A: MEDI6012 | Participants received 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. |
| BG002 | Cohort B: Placebo | Participants received 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. |
| BG003 | Cohort B: MEDI6012 | Participants received 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Primary efficacy analysis population included randomized participants with a Thrombolysis in Myocardial Infarction (TIMI) flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | Percentage of global infarct size | 70 to 84 days post Day 1 dose |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Ejection Fraction (LVEF) | The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported. | Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | Percentage of LVEF | 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The CTA analysis population included randomized participants in the 6-dose regimen who received a full treatment course of study drug, were eligible, and had coronary CTA. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | mm^3 | Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Mass by Late Gadolinium Enhancement (LGE) | The left ventricular mass by LGE is reported. | Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | g | 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI) | The left ventricular mass by cine MRI is reported. | Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | g | 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End-diastolic and End-systolic Volume | Left ventricular end-diastolic and end-systolic volume is reported. | Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | mL | 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Left Ventricular End-diastolic and End-systolic Volume Index | Left ventricular end-diastolic and end-systolic volume index is reported. | Primary efficacy analysis population included randomized participants with a TIMI flow Grade 0-1 on initial angiography who received at least 2 doses of study drug and grouped according to assigned treatment. 'Number of participants analyzed' denotes the number of participants evaluated for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | mL/m^2 | 70 to 84 days post Day 1 dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | As-treated population included all treated participants, grouped according to actual treatment received. | Posted | Count of Participants | Participants | Day 1 through Day 195 post Day 1 dose |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass) | Serum concentration of MEDI6012 is reported. | Pharmacokinetic population included all participants in the As-treated population who had at least one detectable serum concentration measurement for LCAT mass or activity. 'Number analyzed' denotes participants who had adequate pharmacokinetic sample of MEDI6012 for the specified time point. | Posted | Mean | Standard Deviation | ng/mL | Pre- and post-dose on Days 1, 3, 17, and 31 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Immunogenicity population included all treated participants, grouped according to actual treatment received and had at least one serum sample for immunogenicity testing. | Posted | Count of Participants | Participants | Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose |
|
Day 1 through Day 195 post Day 1 dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Cohort A | Participants received placebo matched to MEDI6012 on Day 1 prior to primary percutaneous coronary intervention (pPCI) followed by a second inpatient dose on Day 3 by intravenous (IV) push. | 0 | 90 | 11 | 90 | 28 | 90 |
| EG001 | MEDI6012 Cohort A | Participants received 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. | 2 | 179 | 34 | 179 | 74 | 179 |
| EG002 | Placebo Cohort B | Participants received 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. | 0 | 111 | 24 | 111 | 47 | 111 |
| EG003 | MEDI6012 Cohort B | Participants received 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. | 1 | 195 | 41 | 195 | 89 | 195 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dressler's syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pericardial haemorrhage | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Proctitis haemorrhagic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis a | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Periprocedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Troponin t increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Brachiocephalic arteriosclerosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2020 | Jan 13, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Cohort B: MEDI6012 | Participants received 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. |
|
|
|
|
| OG003 |
| Cohort B: MEDI6012 |
Participants received 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. |
|
|
| OG003 |
| Cohort B: MEDI6012 |
Participants received 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. |
|
|
| OG003 | Cohort B: MEDI6012 | Participants received 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. |
|
|
| OG003 | Cohort B: MEDI6012 | Participants received 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. |
|
|
| OG002 |
| Cohort B: Placebo |
Participants received 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. |
| OG003 | Cohort B: MEDI6012 | Participants received 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. |
|
|
|
| OG003 | Cohort B: MEDI6012 | Participants received 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. |
|
|