E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-segment elevation myocardial infarction Non ST-segment elevation myocardial infarction |
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E.1.1.1 | Medical condition in easily understood language |
Major versus minor heart attack |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053460 |
E.1.2 | Term | Antiplatelet therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064347 |
E.1.2 | Term | Non ST segment elevation myocardial infarction |
E.1.2 | System Organ Class | 100000004849 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064345 |
E.1.2 | Term | ST segment elevation myocardial infarction |
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 |
To demonstrate the degree and time-course of platelet inhibition of both prasugrel and ticagrelor when given acutely before emergency primary angioplasty for STEMI, during the procedure and in the following 4 hours.
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E.2.2 | Secondary objectives of the trial |
To determine if acute STEMI per se leads to reduced antiplatelet activity ( with prasugrel or ticagrelor) when compared to a more stable cohort of patients presenting with NSTEMI/UA who are treated with the same agents. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Patients presenting with STEMI for PCI (characterized by chest discomfort, and prominent ST-segment elevation) 2)Patients presenting with NSTEMI (characterized by chest discomfort, raised levels of myocardial enzymes and/or ST-segment depression or prominent T wave inversion) 3)Able to give verbal consent (STEMI patients pre procedure) and/or written consent (STEMI after procedure and NSTEMI patients prior to enrolment). 4)Age>18 years of age 5)Able to take Aspirin and either prasugrel or ticagrelor. 6)Have no concurrent septic or inflammatory illness 7)Thienopyridine naive
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E.4 | Principal exclusion criteria |
1)Be unable to provide verbal and written consent 2)Allergic to aspirin or any of the P2Y12 antagonists in the trial 3)Have pre-existing cardiogenic shock 4)Have a concurrent septic or inflammatory disease e.g. rheumatoid arthritis, lupus, pneumonia. 5)Already taking a P2Y12 inhibitor 6)Known bleeding diathesis 7)Patients under 75 years of age or under 60 kg or those who have had a previous stroke/transient ischaemic attack, will not be eligible for prasugrel but rather ticagrelor. 8)Patients with a history of intracranial haemorrhage will not receive prasugrel or ticagrelor but rather will receive treatment with clopidogrel.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) The degree of platelet inhibition generated by prasugrel vs ticagrelor from the time of loading dose administration and during the following 4 hours of therapy in pateints with STEMI and NSTEMI
2) To assess whether there is a difference in antiplatelet activity of Ticagrelor and Prasugrel in patients with STEMI vs NSTEMI. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
We are propsosing to collect blood samples for analysis at 20 mins, first balloon inflation (STEMI patients only), 60 mins, and 4 hours after loading with a P2Y12 receptor antagonist. |
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E.5.2 | Secondary end point(s) |
To determine the concentration of prasugrel and ticagrelor active metabolite in plasma from the time of administration and during the following 4 hours. This will be measured using liquid chromatography with tandem mass spectrometry. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
We are propsosing to collect blood samples for analysis at 20 mins, 60 mins, and 4 hours after loading with a P2Y12 receptor antagonist. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 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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When the target number of patients has been reached, all samples have been analysed, and the full data set has been reviewed and analysed. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | 2 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 2 |