Exploring the efficacy of once daily oral rivaroxaban for treatment of thrombus in left atrial/left atrial appendage in subjects with nonvalvular atrial fibrillation or atrial flutter

• Conditions: Atrial Fibrillation; MedDRA version: 17.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 17.0Level: PTClassification code 10003662Term: Atrial flutterSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001062-15-PL
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Men or women aged >/= 18 years
- Hemodynamically stable nonvalvular AF or atrial flutter
- LA/LAA thrombus documented at baseline by transesopheagel echocardiography (TEE) up to 72 hours prior to start of study medication
- vitamin K antagonist(s) (VKA)/ new oral anticoagulant(s) (NOAC)-naïve or untreated within 1 month prior to signing of the informed consent form or VKA pretreated but under ineffective INR levels (< 2.0, documented with at least 2
consecutive measurements that are at least 24 hours apart) within last 6
weeks
- Women of childbearing potential and men must agree to use adequate contraception when sexually active

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- Transient Ischemic Attack within 3 days prior to study inclusion
- Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
- Acute myocardial infarction within the last 14 days prior to study inclusion
- Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, active endocarditis, Intracardiac tumor, known left ventricular or aortic thrombus
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- Concomitant drugs/therapies: Indication for anticoagulant therapy for a condition other than nonvalvular AF or atrial flutter (eg, VTE). Concomitant use of anticoagulant drugs, including VKA, or factor IIa or factor Xa inhibitors. Chronic aspirin therapy >100 mg or dual antiplatelet therapy. Concomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents—ketoconazole, itraconazole, voriconazole, and posaconazole—if used systemically
- Concomitant conditions: Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. Hypersensitivity to investigational treatment. Calculated creatinine clearance [CrCl] < 15 mL/minute at the screening visit. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk. Any severe condition that would limit life expectancy to less than 3 months (eg, advanced malignancy, etc.). Planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment TEE. Inability to take oral medication. Ongoing drug addiction or alcohol abuse

Study & Design

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