E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients treated with clopidogrel candidates for coronary angioplasty for ST-segment elevation acute coronary syndrome or stable angina |
pazienti trattati con clopidogrel candidati ad angioplastica coronarica per sindrome coronarica acuta senza ST sopraslivellato o angina stabile |
|
E.1.1.1 | Medical condition in easily understood language |
ischemic heart disease |
cardiopatia ischemica |
|
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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 |
prevention of major adverse cardiac events in patients undergoing coronary angioplasty |
prevenzione eventi cardiaci avversi maggiori in soggetti sottoposti ad angioplastica coronarica |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of peri-procedural residual platelet reactivity;incidence of peri-procedural myocardial injury; Incidence of bleeding complications. |
Valutazione peri-procedurale della reattività piastrinica residua; incidenza di danno miocardico peri-procedurale;Incidenza di complicanze emorragiche. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with stable angina, myocardial ischemia and inducible indication to perform coronary angiography, or 2. Patients with NSTE-ACS (unstable angina or myocardial infarction without ST-segment overlined) that require an early invasive strategy |
1. Pazienti con angina stabile, ischemia miocardica inducibile ed indicazione ad eseguire coronarografia, oppure 2. Pazienti con NSTE-ACS (Angina instabile o infarto miocardico senza sovraslivellamento del tratto ST) che necessitano di una strategia invasiva precoce |
|
E.4 | Principal exclusion criteria |
1. Patients who require primary angioplasty for myocardial infarction with ST-segment overlined 2. Patients with platelet counts below 70 × 109 / L 3. Patients undergoing surgery for coronary artery bypass graft in the previous three months 4. Patients with a recent episode of major bleeding (<6 months) |
1. Pazienti che necessitano di angioplastica primaria per infarto miocardico con sovraslivellamento del tratto ST 2. Pazienti con conta piastrinica inferiore a 70 × 109/L 3. Pazienti sottoposti ad intervento di by-pass aorto-coronarico nei precedenti tre mesi 4. Pazienti con recente episodio di sanguinamento maggiore (< 6 mesi) |
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E.5 End points |
E.5.1 | Primary end point(s) |
30-day incidence of coronary dall'angioplastica major adverse cardiac events (death, myocardial infarction or revascularization new "target") and in patients enrolled in the registry than in those randomized. The peri-procedural myocardial infarction is defined as an increase in post-angioplasty values of CK-MB> 3 times normal. |
Incidenza a 30 giorni dall’angioplastica coronarica di eventi cardiaci avversi maggiori (morte, infarto miocardico o nuova rivascolarizzazione del vaso “target”), sia nei pazienti arruolati nel registro che in quelli randomizzati. L’infarto peri-procedurale sarà definito come aumento post-angioplastica dei valori di CK-MB >3 volte il valore normale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Evaluation of peri-procedural residual platelet reactivity 2. Incidence of peri-procedural myocardial injury, defined as any increase in markers of post-angioplasty miocardionecrosi above the normal limit 3. Incidence of bleeding complications according to TIMI criteria |
1. Valutazione peri-procedurale della reattività piastrinica residua 2. Incidenza di danno miocardico peri-procedurale, definito come qualsiasi aumento post-angioplastica dei markers di miocardionecrosi al di sopra del limite di normalità 3. Incidenza di complicanze emorragiche secondo i criteri TIMI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
|
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 14 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |