E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention. |
Pazienti con malattia coronarica caratterizzata da stenosi di lunghezza superiore a 25 mm e rivascolarizzati mediante angiopolastica coronarica percutanea elettiva ed impianto di stent. |
|
E.1.1.1 | Medical condition in easily understood language |
patients with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention. |
Pazienti con malattia coronarica caratterizzata da stenosi di lunghezza superiore a 25 mm e rivascolarizzati mediante angiopolastica coronarica percutanea elettiva ed impianto di stent. |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011089 |
E.1.2 | Term | Coronary artery stenosis |
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 |
To assess the safety and efficacy of routine usage of the bivalirudin vs Heparin to avoid periprocedural myocardial necrosis. |
Valutare la sicurezza el'efficacia dell'uso routinario della Bivalirudina in comparazione con quello dell'Eparina non frazionata in sala di emodinamica per ridurre l'incidenza della necrosi miocardica periprocedurale. |
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E.2.2 | Secondary objectives of the trial |
Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months. |
valutare l'incidenza degli eventi cardiovascolari e cerebrovascolari maggiori, sanguinamenti maggiori e minori dopo 1,6 e 12 mesi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
sign informed consent; age>18 years; patients with stable or unstable angina pectoris; de novo lesion with total lenght >25 mm; |
firma del consenso informato, età >18 anni, pazienti con angina pectoris stabile o instabile; stenosi coronarica >25 mm di lunghezza; |
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E.4 | Principal exclusion criteria |
serum creatinine>2,5 mg/dl; pregnancy; ST elevation myocardial infarction; ongoing serious bleeding; previous stroke;Hemodynamic instability |
creatinina >2,5 mg/dl; gravidanza; infartoi miocardico con ST sopralivellato; sanguinamenti massivi in atto; pregressi stroke; instabilità emodinamica |
|
E.5 End points |
E.5.1 | Primary end point(s) |
to value the incidence of periprocedural myonecrosis defined as a peak postprocedural CK.MB elevation>1 time the upper limit of normal, alone or associated with chest pain or ST segment or T wave abnormalities, in patients undergoing non urgent percutaneous myocardial revascularization. |
valutare l'incidenza della necrosi miocardica periprocedurale definita come un rialzo della CK-MB>1 volta il limite del normale, associata o meno ad elevazione del segmento ST o a dolore toracico o ancora ad inversione delle onde T, in pazienti sottoposti a rivascolarizzazione miocardica percutane elettiva. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6, 12 and 24 hours after the rivascolarization procedure. |
6, 12 e 24 ore dopo la procedura di rivascolarizzazione. |
|
E.5.2 | Secondary end point(s) |
Rate of major adverse cerebro-cardiovascular events, major and minor bleeding at 1, 6 and 12 months. |
valutare l'incidenza degli eventi cardiovascolari e cerebrovascolari maggiori, sanguinamenti maggiori e minori dopo 1,6 e 12 mesi |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days, 6 and 12 months |
30 giorni, 6 e 12 mesi |
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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 | Yes |
E.6.3 | Therapy | Yes |
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) | 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
| No |
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 | 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 | 24 |
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 | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |