stable CAD
Conditions
Interventions
Product Name: Acido Acetilsalicilico
Product Code: [B01AC06]
Pharmaceutical Form: Tablet
Current Sponsor code: B01AC06
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ---;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.;Timepoint(s) of evaluation of this end point: 7 days | — |
Countries
Italy
Contacts
Public Contactcentro clinical trial
AOU Maggiore della Carità di Novara
Outcome results
None listed