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

• Register: EUCTR
• Last refreshed on: 16 November 2015
• Main ID: EUCTR2012-001062-15-DE
• Date of registration: 26/03/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: 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
• Scientific title: An open-label, international, multicenter, interventional study exploring the efficacy of once-daily oral rivaroxaban (BAY 59-7939) for the treatment of left atrial/left atrial appendage thrombus in subjects with nonvalvular atrial fibrillation or atrial flutter - X-TRA
• Date of first enrolment: 13/06/2013
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001062-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Bulgaria, France, Germany, Poland, Russian Federation, Turkey, Ukraine

Contacts

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

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, Intracardiac tumor, known left ventricular or aortic thrombus, active endocarditis
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Atrial Fibrillation
MedDRA version: 16.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 16.1 Level: PT Classification code 10003662 Term: Atrial flutter System Organ Class: 10007541 - Cardiac disorders

Intervention(s)

Trade Name: Xarelto
Product Name: Rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY-59-7939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-

Trade Name: Xarelto
Product Name: Rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): The primary end point is the percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment.
Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesopheagel echocardiography

Secondary Objective: The secondary objectives of the study are to describe the categories of thrombus outcome in subjects (based on whether resolved, reduced, unchanged, larger, or new) confirmed on TEE at the end-of-treatment visit (after 6 weeks of treatment); describe the incidence of the composite of stroke and non-CNS systemic embolism at the end-of-treatment visit (after 6 weeks of treatment) and during follow-up; describe the incidence of all bleeding (major and non-major) events at the end-of-treatment visit (after 6 weeks of treatment) and during follow-up.

Timepoint(s) of evaluation of this end point: At 6 weeks after the start of study drug

Main Objective: The primary objective of the study is to explore the effect of rivaroxaban on the complete
resolution of LA/LAA thrombi at the end-of-treatment visit (after 6 weeks of treatment) in
subjects with nonvalvular AF or atrial flutter who have LA/LAA thrombus confirmed by TEE.
The term nonvalvular AF is used to imply that AF is not related to rheumatic valvular disease
(predominantly mitral stenosis) or prosthetic heart valves

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For categories of thrombus outcome, it is at 6 weeks after the start of study drug.
For composite number of stroke, non-central nervous system systemic events, it is upto 12 weeks after the start of study drug

Secondary end point(s): 1) Categories of thrombus outcome: resolved, reduced, unchanged, enlarged or new
2) The composite number of stroke and non-central nervous system systemic embolism events
3)The number of all bleeding events

Secondary ID(s)

BAY59-7939/16320

Source(s) of Monetary Support

Bayer HealthCare AG