Effects on human body of Rivaroxaban in patients with coronary artery disease and atrial fibrillation.

Phase 1

• Conditions: stable CAD; history of atrial fibrillation; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; MedDRA version: 20.0Level: LLTClassification code 10021279Term: IHDSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2020-005110-17-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

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

¿ 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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