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

Atrial Fibrillation Clinical Trial

— X-TRA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839357
• Other study ID #: 16320
• Secondary ID: 2012-001062-15
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2013
• Last updated: July 22, 2016
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesBulgaria: Bulgarian Drug AgencyRussia: Ministry of Health of Russian FederationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUkraine: State Expert Center Ministry of Health of UkraineTurkey: Ethics Committee, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women aged >/= 18 years

• Hemodynamically stable nonvalvular AF or atrial flutter

• LA/LAA thrombus documented at baseline by transesophageal 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

• 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

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 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, venous thromboembolism). 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 20 mg orally once daily for 6 weeks; subjects with severe to moderate renal impairment (ie, CrCl of 15 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily for 6 weeks in the study.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 transesophageal echocardiography	After 6 weeks	No
Secondary	Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new		After 6 weeks	No
Secondary	The composite number of stroke and non-central nervous system systemic embolism events		Up to 12 weeks	No
Secondary	The number of all bleeding events		Up to 12 weeks	Yes

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