E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute myocardial infarction decided for treatment by percutaneous coronary intervention (PCI) are included. The test drug mangafodipir is administered intravenously just prior to PCI. The objective is to prevent reperfusion injury on return of blood flow to the ischemic myocardium. If mangafodipir proves successful, the infarct size will be smaller, and the condition of the patient improved during the acute phase and thereafter |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 objective of the present trial is to find out whether mangafodipir, being a potent cardioprotective drug in animal studies, prevents reperfusion injury and reduces infarct size in patients during acute myocardial infarction. |
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E.2.2 | Secondary objectives of the trial |
To find out whether mangafodipir given as a therapeutic adjunct to primary coronary intervention (primary PCI) reduces postischemic release to plasma of biomarkers of myocardial injury and reduces myocardial infarct size assessed by cardiac MRI at about 2 months following the acute heart attack. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Males 40-80 years and females 50-80 years with AMI ( acute myocardial infarction)
b. Chest pain up to 6 hours.
c. ST segment elevation in two neighbouring leads in the anterior wall (≥ 0.2 mV) or in the inferior wall (≥ 0.1 mV) of the left ventricle.
d. Decided for treatment by primary PCI.
e. TIMI grade 0 flow in the occluded LAD/RCA artery
f. Written informed consent.
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E.4 | Principal exclusion criteria |
a. Previous coronary artery bypass operation.
b. Previous AMI.
c. Chest pain more than 6 hours.
d. Angina within 48 hours before admission.
e. Cardiac arrest and cardiogenic shock.
f. Occlusion of other coronary arteries than LAD.
g. Known hypersensitivity to mangafodipir (as contrast agent for MRI).
h. Received mangafodipir ≤ 5 weeks before admission
i. History of prior serious allergic or pseudo-allergic reaction
j. Severely reduced liver or renal function
k. Any other serious illness or medical condition
l. Fertile females
m. Phaeochromocytoma
n. Thrombolytic treatment applied before primary PCI
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point will be release of biomarkers (CK-MB and Troponin T) to plasma at 6 hours after PCI. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary end-points will be accumulated plasma CK-MB and cTnT over 48 hours after PCI
Regression of ST segment elevation at end of ichemia measured at 6 and 48 hours after reperfusion and expressed in mV and assessment of infarct size and cardiac function by MRI at 6-10 weeks after AMI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
over 48 hours after PCI, after 6 and 48 hours after reprefussion and at 6-10 weeks after AMI |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |