E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Myocardial Infartion to be treated with primary PCI |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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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 primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to primary PCI.
Primairy endpoint: Infarct size measured as the final infarct size on Delayed Enhancement (DE) MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3-5 days. |
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E.2.2 | Secondary objectives of the trial |
-To assess feasibility of this pilot trial -To assess side effects of exenatide during acute myocardial infarction |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- >18 and < 80 years of age - First myocardial infarction - ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG) - Time from onset of complaints at least 2 hours at presentation. - Delay between onset of sustained chestpain and PCI < 6 hours.
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E.4 | Principal exclusion criteria |
- Cardiac rhythm is other than normal sinus rhythm. - Patient in Killip class 3 or 4 of heart failure - Cardiogenic shock defined as sustained systolic blood pressure ≤ 80mmHg despite fluid hydration. - Post cardiac resuscitation - Need for intra aortic balloon counterpulsation therapy - The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness - No former PCI performed - No recanalisation achieved of the occluded coronary artery - Culprit not in segment 1,2,3,6,7,11,12,13 of the coronary artery - No definite culprit - More than one occluded vessel, or a more than 70% stenosis by visual assessment in a non-culprit vessel. - TIMI 3 flow in culprit lesion at presentation - Decreased renal function eGFR < 50ml/min - Any contraindication for MRI ie: implanted electronic devices such as pacemakers, internal defibrillators, neurostimulators, implanted drug infusion devices, cochlear implants, cerebrovascular clips, claustrophobia. previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, venous umbrella spinal/intra-ventricular shunts - Metal fragments in eye, head, ear, skin or shoulder. - Swann-Ganz catheter. - Known pre-existing left ventricular dysfunction measured by any technique (ejection fraction < 45% prior to current admission for myocardial infarction) - Prior myocardial infarction - Prior coronary artery bypass grafting - Moderate to severe cardiac valve disease - Stroke or transient ischemic attack within the previous 24 hours - Serious known concomitant disease with a life expectancy of less than one year - Follow up impossible - Previous participation in a trial within the previous 30 days - Known type I Diabetes Mellitus - Known type II Diabetes Mellitus - Pregnancy and/or lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
Infarct size measured as the final infarct size on DE MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3-5 days. |
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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 | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |