E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
stable CAD; history of atrial fibrillation |
coronaropatia stabile; storia di fibrillazione atriale. |
|
E.1.1.1 | Medical condition in easily understood language |
stable coronary artery disease; history of atrial fibrillation. |
malattia coronarica stabile; storia di fibrillazione atriale. |
|
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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021279 |
E.1.2 | Term | IHD |
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 |
The study will evaluate the pharmacodynamic and “pleiotropic” effects of Rivaroxaban vascular dose on top of aspirin (100 mg daily) in a population of patients with stable CAD, compared with the effects of Rivaroxaban given at dosing regimen approved for the prevention of atrial fibrillation (AF)-related thromboembolic complication (20 mg daily) added to aspirin (100 mg daily) in patients stable CAD. |
Lo studio valuterà gli effetti farmacodinamici e "pleiotropici" di Rivaroxaban a dosaggio vascolare in associazione ad aspirina (100 mg al giorno) in una popolazione di pazienti con CAD stabile, rispetto agli effetti di Rivaroxaban somministrato al regime posologico approvato per la prevenzione delle complicanze tromboemboliche correlatae alla fibrillazione atriale (20 mg al giorno) aggiunta ad aspirina (100 mg al giorno) in pazienti con CAD stabile. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In group A and C will be included patients without AF and with stable CAD (previous MI > 1 year), and at least one of the following additional factors: ¿ PAD (Peripheral Artery Disease) ¿ Diabetes mellitus (DM) ¿ Chronic kidney disease (CKD) Group B will comprise patients with AF and stable CAD (previous MI > 1 year), and at least one of the following additional factors: ¿ PAD (Peripheral Artery Disease) ¿ Diabetes mellitus (DM) ¿ Chronic kidney disease (CKD) |
Nel gruppo A e C saranno inclusi i pazienti senza FA e con CAD stabile (IM precedente > 1 anno) ed almeno uno dei seguenti fattori aggiuntivi: ¿ PAD (arteriopatia periferica) ¿ Diabete mellito (DM) ¿ Malattia renale cronica (CKD) Il gruppo B comprenderà pazienti con FA e CAD stabile (IM precedente> 1 anno) e almeno uno dei seguenti fattori aggiuntivi: ¿ PAD (arteriopatia periferica) ¿ Diabete mellito (DM) ¿ Malattia renale cronica (CKD) |
|
E.4 | Principal exclusion criteria |
¿ Known hypersensitivity to the active substance or any of the excipients. ¿ Active clinically significant bleeding. ¿ Injuries or conditions that constitute a significant risk of major bleeding (these may include recent or ongoing gastric ulceration, presence of malignant neoplasms at high risk of bleeding, recent cerebral or spinal traumatism, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities). ¿ Concomitant treatment with other anticoagulants, such as unfractionated heparins, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.) or chronic oral anticoagulant therapy. ¿ Previous hemorrhagic or lacunar stroke, or any stroke within 1 month. ¿ Hepatic disease associated with coagulopathy and clinically-relevant bleeding risk, including cirrhotic patients with Child Pugh B and C. ¿ Creatinine clearance <30 mL / min (estimated) ¿ Pregnancy and breast-feeding. |
¿ Ipersensibilità nota al principio attivo o ad uno qualsiasi degli eccipienti. ¿ Sanguinamento clinicamente significativo attivo. ¿ Lesioni o condizioni che costituiscono un rischio significativo di sanguinamento maggiore (possono comprendere ulcerazione gastrica recente o in corso, presenza di neoplasie maligne ad alto rischio di sanguinamento, traumatismo cerebrale o spinale recente, recente chirurgia cerebrale, spinale o oftalmica, recente emorragia intracranica, varici esofagee note o sospette, malformazioni artero-venose, aneurismi vascolari o principali anomalie vascolari intraspinali o intracerebrali). • Trattamento concomitante con altri anticoagulanti, come eparine non frazionate, eparine a basso peso molecolare (enoxaparina, dalteparina, ecc.), Derivati ¿¿dell'eparina (fondaparinux, ecc.) O terapia anticoagulante orale cronica. ¿ Precedente ictus emorragico o lacunare o qualsiasi ictus entro 1 mese. ¿ Malattia epatica associata a coagulopatia e rischio di sanguinamento clinicamente rilevante, inclusi i pazienti cirrotici con Child Pugh B e C. ¿ Clearance della creatinina <30 mL / min (stimata) ¿ Gravidanza e allattamento. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary study endpoint will be the comparison over the time variations of Anti Xa activity among the 3 groups. The comparison of platelet aggregation, inflammatory parameters, endothelial function and thrombin generation parameters among the 3 groups will be also performed. |
L'endpoint primario dello studio sarà il confronto tra le variazioni temporali dell'attività Anti fattore - Xa tra i 3 gruppi. Sarà inoltre effettuato il confronto tra aggregazione piastrinica, parametri infiammatori, funzione endoteliale e parametri di generazione della trombina tra i 3 gruppi. |
|
E.5.1.1 | 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 | 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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 3 |
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 | Information not present in EudraCT |
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 | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |