E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary Atheroclerosis |
Aterosclerosi coronarica |
|
E.1.1.1 | Medical condition in easily understood language |
Coronary Atheroclerosis |
Aterosclerosi coronarica |
|
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 | 10003211 |
E.1.2 | Term | Arteriosclerosis coronary artery |
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 compare the effects of different aspirin regimens ( 100mg/d, 200mg/d, 100+100 mg b.i.d.) to patients undergoing coronary artery bypass grafting and/or aortic valve replacement with bioprosthesis on platelet thromboxane A2 biosynthesis and on the secretion of new platelets into circulation. |
Paragonare l’effetto della somministrazione di aspirina ( dose singola 100mg/die, dose singola 200mg/die, dose doppia 100 + 100 mg/die) a pazienti sottoposti a bypass aortocoronarico e/o sostituzione valvolare aortica con bioprotesi sulla biosintesi di trombossano A2 piastrinico e sulla generazione di nuove piastrine. |
|
E.2.2 | Secondary objectives of the trial |
To determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1 |
Stabilire se in questi pazienti sia necessario un diverso (più breve) intervallo di somministrazione, al fine di inibire completamente ed in modo persistente la COX-1 piastrinica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• informed consent of the study signed
• coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
• age between 55 and 80
• ejection fraction> 30%. |
• firma del consenso informato dello studio
• intervento di bypass aortocoronarico e/o intervento di sostituzione di valvola aortica mediante bioprotesi
• età compresa tra i 55 e gli 80
• frazione di eiezione > 30%. |
|
E.4 | Principal exclusion criteria |
• excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding
• perioperative myocardial infarction
• stroke or renal failure requiring dialysis and need of post-operative anticoagulation
• patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
• patients undergoing off-pump coronary artery bypass graft
• overt kidney or liver disease
• therapies that influence the coagulation
• fertile women |
• sanguinamento eccessivo (> 1000mL/6 h) o la necessità di re intervento per sanguinamento
• infarto miocardico perioperatorio
• ictus o insufficienza renale che richiede dialisi e necessità di terapia anticoagulante post-operatoria
• pazienti sottoposti a bypass aortocoronarico conseguentemente ad una procedura di rivascolarizzazione coronarica percutanea fallita
• pazienti sottoposti a bypass aortocoronarico off-pump
• malattia renale o epatica conclamata
• terapie che influenzano la coagulazione
• donne in età fertile |
|
E.5 End points |
E.5.1 | Primary end point(s) |
variation of the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin |
variazione dei livelli di TXB2 e 12-HETE nel siero a 12 e 24 ore dopo la somministrazione di aspirina |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 and 24 hours after administration |
12 e 24 ore dopo la somministrazione |
|
E.5.2 | Secondary end point(s) |
change in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 urinary, 2-3 dinor-6-chetoPGF1 , Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin |
variazione dei livelli di 11-deidro TXB2 urinario, 8-iso-PGF2 urinario, 2-3 dinor-6-chetoPGF1, Verify-NOW Aspirin, piastrine reticolate a 12 e 24 ore dopo la somministrazione di aspirina |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
12 and 24 hours after administration |
12 e 24 ore dopo la somministrazione |
|
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 | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
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 | 12 |
E.8.9.1 | In the Member State concerned days | 0 |