E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH CAD AFTER CORONARY ANGIOPLASTY |
PAZIENTI AFFETTI DA CARDIOPATIA ISCHEMICA DOPO ANGIOPLASTICA CORONARICA |
|
E.1.1.1 | Medical condition in easily understood language |
PATIENTS WITH CAD AFTER CORONARY ANGIOPLASTY |
PAZIENTI AFFETTI DA CARDIOPATIA ISCHEMICA DOPO ANGIOPLASTICA 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 | 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 |
EFFECTIVENESS OF treatment with ivabradine ON ENDOTHELIAL FUNCTION IN PATIENTS WITH CAD UNDERWENT TO CORONARY ANGIOPLASTY |
EFFICACIA DEL TRATTAMENTO CON IVABRADINA SULLA FUNZIONE ENDOTELIALE DI PAZIENTI AFFETTI DA CARDIOPATIA ISCHEMICA SOTTOPOSTI AD ANGIOPLASTICA |
|
E.2.2 | Secondary objectives of the trial |
INCIDENCE O FMACE |
VALUTAZIONE INCIDENZA DI MACE (MORTE, INFARTO MIOCARDICO, RIVASCOLARIZZAZIONE DEL VASO TARGET DEL PCA) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
ISCHEMIC HEART DISEASE PATIENTS TREATED WITH CORONARY ANGIOPLASTY AND ON TOP OF MEDICAL TREATMENT |
PAZEINTI AFFETTI DA CARDIOPATIA ISCHEMICA TRATTATI CON ANGIOPLASTICA CORONARICA E IN TERAPIA MEDICA MASSIMALE |
|
E.4 | Principal exclusion criteria |
Patients with resting heart rate <60 bpm.
Patients undergoing revascularization for STEMI.
Patients with severe left ventricular dysfunction (ejection fraction ≤ 35%).
Patients with chronic renal failure, severe (GFR <60 ml / min).
Patients with liver disease.
Patients with atrial fibrillation and atrial flutter.
Patients with pacemakers.
Patients with disease of the sinoatrial node, sinoatrial block, long QT syndrome, complete AV block.
Patients with chronic inflammatory disease and cancer. |
Pazienti con frequenza cardiaca a riposo < 60 bpm.
Pazienti sottoposti a rivascolarizzazione per STEMI.
Pazienti con severa disfunzione ventricolare sinistra (frazione d’eiezione ≤35%).
Pazienti con insufficienza renale cronica di grado severo (GFR< 60 ml/min).
Pazienti con epatopatie.
Pazienti affetti da fibrillazione atriale e flutter atriale.
Pazienti con pacemaker.
Pazienti affetti da malattia del nodo seno-atriale, blocco seno-atriale, sindrome del QT lungo, blocco AV completo.
Pazienti affetti da malattia infiammatoria cronica e neoplasie. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
EVALUATION OF ENDOTHELIAL MARKER FUNCTION AND INFLAMMATORY INDICES IN THE TIMING OF THE STUDY |
VALUTAZIONE DEI MARKER DI FUNZIONE ENDOTELIALE E DEGLI INDICI INFIAMMATORI NEI TIMING DELLO STUDIO |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
FIRST ASSESSMENT TO 4 WEEKS AND THEN TO 8 WEEKS |
PRIMA VALUTAZIONE A 4 SETTIMANE E POI A 8 SETTIMANE |
|
E.5.2 | Secondary end point(s) |
INCIDENCE OF MACE |
INCIDENZA MACE |
|
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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.8.4.1 | 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 | 16 |
E.8.9.1 | In the Member State concerned days | 0 |