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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001062-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new | After 6 weeks | |
| The composite number of stroke and non-central nervous system systemic embolism events | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plovdiv | 4000 | Bulgaria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25819852 | Derived | Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6. |
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| The number of all bleeding events | Up to 12 weeks |
| Sofia |
| 1309 |
| Bulgaria |
| Sofia | 1750 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Créteil | 94010 | France |
| Marseille | 13005 | France |
| Paris | 75571 | France |
| Toulouse | 31059 | France |
| Hamburg | Free and Hanseatic City of Hamburg | 20099 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Leipzig | Saxony | 04289 | Germany |
| Berlin | State of Berlin | 13353 | Germany |
| Krakow | 31-121 | Poland |
| Lodz | 91-347 | Poland |
| Lublin | 20-954 | Poland |
| Warsaw | 02-005 | Poland |
| Warsaw | 02-507 | Poland |
| Wroclaw | 50-420 | Poland |
| Moscow | 115093 | Russia |
| Moscow | 117997 | Russia |
| Moscow | 121552 | Russia |
| Saint Petersburg | 194156 | Russia |
| Saratov | 410039 | Russia |
| Istanbul | 34662 | Turkey (Türkiye) |
| Istanbul | 34846 | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Samsun | 55139 | Turkey (Türkiye) |
| Donetsk | 83045 | Ukraine |
| Kiev | 03680 | Ukraine |
| Odesa | 65025 | Ukraine |
| Uzhhorod | 88000 | Ukraine |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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