E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment for cardiac reperfusion injury in patients undergoing PCI( Percutaneous coronary intervention) to treat an AMI (Acute Myocardial Infarction) and to assess safety as well as the ability of TRO40303 to reduce infarct size using biomarkers and MRI (Magnetic Resonance Imaging) |
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E.1.1.1 | Medical condition in easily understood language |
The aim of the study is to investigate the heart protective effects of TRO40303 through reducting reperfusion injury |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000930 |
E.1.2 | Term | Acute myocardial infarction, unspecified site, initial episode of care |
E.1.2 | System Organ Class | 100000004849 |
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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 aim of this study is to assess the efficacy of TRO40303 administered just before balloon inflation during percutaneous coronary intervention (PCI) to reduce infarct size due to reperfusion injury in patients treated for acute myocardial infarction (AMI). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial is to assess the safety of TRO40303 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male and Female with non child-bearing potential (post menopausal, ovariectomised or hysterectomised) patients. Menopause is defined as age > 60 years, or between 45 and 60 years being amenorrheic for at least 2 years.
2.Age>18 years old
3.First acute myocardial infarction
4.Occlusion should affect the following coronaries: the Left Anterior Descending artery (LAD) or the dominant or balanced Right Coronary Artery (RCA) or the dominant or balanced left circumflex artery (LCx).
5.Acute myocardial infarction defined as
a)nitrate resistant chest pain ≥ 30 min
b)ST-segment elevation ≥ 2 mm in at least two contiguous chest leads. This inclusion criterion regarding ST elevation can be superseded by inclusion criterion 7.
6.Presenting within 6h of onset of chest pain
7.Clinical decision to treat with percutaneous coronary intervention
8.Occlusion of culprit artery with a Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-1 at time of admission and before percutaneous coronary intervention.
9.Have signed an Informed Consent to participate to the trial before any study related procedure has been taken.
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E.4 | Principal exclusion criteria |
1.Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous AMI, angina within 48h before infarction, previous CABG, treatment with intravenous fibrinolytic therapy within the 72 hours prior to PCI.
2.Atrial fibrillation (could confound CMR analysis)
3.Pace-maker
4.Concurrent inflammatory, infectious or malignant disease
5Biliary obstruction or hepatic insufficiency at the time of inclusion in the study based on patient questioning
6.Be possibly dependant on the Investigator or the Sponsor (eg including but not limited to affiliated employee)
7.Participated in any other international drug or therapy study with a non-approved medication, within the previous 3 months.
8.Patient under guardianship
9. History or presence of egg allergy based upon patient questioning |
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-Primary endpoints: Infarct size expressed as area under the curve (AUC) for creatine kinase (CK) and AUC of troponin I |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood samples will be obtained at admission and repeatedly over the next 3 days (blood sampling at 6h, 12h, 18h, 24h, 36h, 48h and 72h after stenting). And also day 30. |
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E.5.2 | Secondary end point(s) |
- infarct size normalized to the myocardium at risk assessed by CMR.
-Left ventricular function after PCI will be assessed by CMR and echocardiography performed between D3 and D5, echocardiography being repeated at Day 30.
-An assessment of ST-segment decrease after PCI will be performed by comparing the pre-PCI ECG to an ECG performed one hour post stenting.
-The amount of microvascular obstruction will be assessed by CMR.
-Transmural extension of infarct will be assessed by CMR.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-CMR :Between D3 and D5
-Echocardiography : between D3 and D5 , repeated at D30
-ECG : Pre-PCI and one hour post stenting |
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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 | Yes |
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 | Yes |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 27 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 27 |
E.8.9.2 | In all countries concerned by the trial days | 0 |