E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of ST-elevated myocardial infarction (STEMI) after percutaneous intervention (PCI) |
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E.1.1.1 | Medical condition in easily understood language |
Acute myocardial infarction |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064346 |
E.1.2 | Term | STEMI |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main goal of this study is to evaluate efficacy of a single administration of ATH3G10 in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). |
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E.2.2 | Secondary objectives of the trial |
To investigate effects on myocardial salvage index (MSi) measured by MRI To investigate the safety and tolerability of ATH3G10
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of informed consent 2. Symptoms and signs consistent with acute MI and ST elevation at the J-point in two contiguous leads (cut-points: >0.2mV in men and >0.15 mV in women in leads V2-V3 and/or >0.1 mV in other leads) 3. Start of PCI, defined as when the guide wire is passed through the stenosis, less than 4 hours after symptom onset. Symptom onset defined as the time of the start of the pain that causes the call to the ambulance. 4. TIMI flow grade 0 at angiography before PCI in left anterior descending coronary artery segment 6 or 7 without collaterals OR TIMI flow grade less than 3 in any infarct related main coronary arteries after PCI. 5. Age 40-85, inclusive
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E.4 | Principal exclusion criteria |
1. Deleted 2. Cardiogenic chock, non-compensated acute heart failure and/or pulmonary oedema. 3. Previous major vascular intervention within the last 4 weeks. 4. History of an infarct in the same artery that is currently affected. 5. Thrombolysis therapy prior to admission.
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E.5 End points |
E.5.1 | Primary end point(s) |
Left Ventricular End-Diastolic Volume index (LV EDVi) change from Visit 2 to Visit 3 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At V3 (3 month post IMP administration) |
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E.5.2 | Secondary end point(s) |
• Safety and tolerability: AEs/SAEs, blood pressure, physical examination, ECG and laboratory assessments including clinical chemistry, haematology and coagulation. • Myocardial Salvage index (MSi) at Visit 2.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At V3 (3 month post IMP administration) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |