E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with chronic stable angina candidates to coronary angioplasty |
pazienti con angina cronica stabile e candidati ad angioplastica coronarica |
|
E.1.1.1 | Medical condition in easily understood language |
patients with stable coronary artery disease treated with angioplasty |
paziente con cardiopatia ischemica stabile trattati con angioplastica |
|
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 |
|
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 |
Incidence in both treatment arms of the combined endpoint of major adverse cardiac events at 30 days |
Incidenza nei due bracci di trattamento dell’end-point combinato di eventi avversi cardiaci maggiori a 30 giorni |
|
E.2.2 | Secondary objectives of the trial |
Change in response to clopidogrel, assessed in terms of residual platelet reactivity Incidence of peri-procedural myocardial injury, defined as any increase in markers of post-angioplasty miocardionecrosi above the normal limit Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications |
Variazione della risposta al clopidogrel, valutata in termini di reattività piastrinica residua Incidenza di danno miocardico peri-procedurale, definito come qualsiasi aumento post-angioplastica dei markers di miocardionecrosi al di sopra del limite di normalità Incidenza di complicanze emorragiche secondo i criteri TIMI (emorragie maggiori: emorragie intracraniche o associate ad una diminuzione di emoglobina di 5 g/dL; emorragie minori: riduzione di emoglobina <5 g/dl) o di complicanze del sito d’accesso |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with stable angina and inducible myocardial ischemia who are candidates for elective percutaneous angioplasty. |
Pazienti con angina stabile ed ischemia miocardica inducibile candidati ad angioplastica percutanea elettiva. |
|
E.4 | Principal exclusion criteria |
Patients with acute coronary syndromes. Patients candidates to receive oral anticoagulant therapy. Patients with thrombocytopenia (platelets <70.000/mm3). Patients who underwent a coronary artery bypass graft in the previous three months. Severe left ventricular dysfunction with left ventricular ejection fraction <30%. Renal failure with creatinine> 2 mg / dl based. Patients with a recent episode of major bleeding (<6 months) |
Pazienti con sindromi coronariche acute. Pazienti candidati a ricevere terapia anticoagulante orale. Pazienti con trombocitopenia (Piastrine <70.000/mm3). Pazienti sottoposti ad intervento di by-pass aorto-coronarico nei precedenti tre mesi. Severa disfunzione ventricolare sinistra con frazione d’eiezione ventricolare sinistra <30%. Insufficienza renale con creatinina > 2 mg/dl di base. Pazienti con recente episodio di sanguinamento maggiore (< 6 mesi) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
incidence of adverse cardiac events at 30 days |
incidenza di eventi avversi cardiaci a 30 giorni |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
bleeding events |
complicanze emorragiche |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |