E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Acute Coronary Syndrome and Diabetes Mellitus |
Pazienti con sindrome coronarica acuta e diabete mellito |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic patients with acute cardiovascular diseases |
Pazienti diabetici con patologie acute cardiache |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 |
We sought to investigate the non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug (primary end-point). |
Ci proponiamo di investigare la non inferiorità dell'effetto antiaggregante in termini di livello di reattività piastrinica (<240 PRU) della dose di carico di Prasugrel (60 mg) contro la dose di carico del Ticagrelor (180 mg) nei pazienti sottoposti ad angioplastica coronarica a 6 ore dalla somministrazione del farmaco. |
|
E.2.2 | Secondary objectives of the trial |
Secondary end-points will be in hospital NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population. |
Gli end point secondari saranno i NACE intraospedalieri (morte cardiovascolare, infarto miocardico, ictus e sanguinamenti in accordo con i criteri TIMI) e la trombosi intrastent nella popolazione di studio |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All consecutive pazients coming with acute coronary syndrome and diabetes mellitus |
Tutti i pazienti consecutivi con sindrome coronarica acuta e diabete mellito |
|
E.4 | Principal exclusion criteria |
Patients without acute coronary syndrome or without diabetes mellitus |
Pazienti senza sindrome coronarica acuta oppure non con diabete mellito |
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E.5 End points |
E.5.1 | Primary end point(s) |
We sought to investigate the non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug (primary end-point). |
Ci proponiamo di investigare la non inferiorità dell'effetto antiaggregante in termini di livello di reattività piastrinica (<240 PRU) della dose di carico di Prasugrel (60 mg) contro la dose di carico del Ticagrelor (180 mg) nei pazienti sottoposti ad angioplastica coronarica a 6 ore dalla somministrazione del farmaco. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood samples will be performed at 2, 6 and 12 hours for the evaluation of the points |
Verranno eseguiti dei prelievi sanguigni a 2, 6 e 12 ore per valutare gli end point |
|
E.5.2 | Secondary end point(s) |
Secondary end-points will be in hospital NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population. |
Gli end point secondari saranno i NACE intraospedalieri (morte cardiovascolare, infarto miocardico, ictus e sanguinamenti in accordo con i criteri TIMI) e la trombosi intrastent nella popolazione di studio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Direct visits or telephone interview will be performed at 1, 6 and 12 months |
Saranno eseguite visite mediche o interviste telefoniche a 1, 6 e 12 mesi |
|
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 | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
| 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 14 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 2 |