Trial Condition(s):
Fibrilación auricular
Explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion (X-VERT)
Bayer Identifier:
15693
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Propósito del ensayo
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.
Criterios de inclusión
- Men or women aged >= 18 years - Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration - Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation - Women of childbearing potential and men must agree to use adequate contraception when sexually active
Criterios de exclusión
- Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization - Transient ischemic attack within 3 days prior to randomization - Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization - Acute Myocardial infarction (MI) within the last 14 days prior to randomization - Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy - Concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used systemically - Concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; 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 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse - Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment - Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Resumen del ensayo
Enrollment Goal
Trial Dates
Phase
¿Podría recibir un placebo?
Products
Accepts Healthy Volunteers
Dónde participar
| Ubicaciones | |
|---|---|
Ubicaciones Centro de investigación Milano, Italy, 20097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Catania, Italy, 95126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Como, Italy, 22020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Bari, Italy, 70021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Venezi, Italy, 30174 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Roma, Italy, 00169 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Kuils River, South Africa, 7580 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Bloemfontein, South Africa, 9301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Cape Town, South Africa, 7450 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación SOWETO, South Africa, 2013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Alberton, South Africa, 1449 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Granada, Spain, 18012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Heraklion, Greece, 711 10 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Thessaloniki, Greece, 54642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Alexandroupolis, Greece, 68100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Attica / Athens, Greece, 11526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Viborg, Denmark, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Herning, Denmark, 7400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación København NV, Denmark, 2400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación LEEUWARDEN, Netherlands, 8934 AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Welwyn Garden City, United Kingdom, AL7 4HQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación ARNHEM, Netherlands, 6815 AD | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación HAARLEM, Netherlands, 2035 RC | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Montreal, Canada, H1T 1C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Turku, Finland, 20521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Lappeenranta, Finland | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Pori, Finland, 28500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Oulu, Finland | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Edmonton, Canada, T5H 3V9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Singapore, Singapore, 168752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Singapore, Singapore, 308433 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Singapore, Singapore, 768828 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Hamilton, Canada, L8L 2X2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación ARRAS, France, 62000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Paris cedex 13, France, 75013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación TOULOUSE cedex, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación VANDOEUVRE-LES-NANCY, France, 54511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Vila Nova de Gaia, Portugal, 4434-502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Lisboa, Portugal, 1169-024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Almada, Portugal, 2801-951 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Carnaxide, Portugal, 2795-53 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Faro, Portugal, 8000-386 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Sao Martinho do Bispo, Portugal, 3041-801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Bournemouth, United Kingdom, BH7 7DW | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Portsmouth, United Kingdom, PO6 3LY | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Chesterfield, United Kingdom, S44 5DX | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Leicester, United Kingdom, LE3 9QP | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Nottingham, United Kingdom, NG5 1PB | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Cliftonville, United Kingdom, NN1 5BD | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación London, United Kingdom, SW17 0RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Rapid City, United States, 57701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Lincoln, United States, 68506 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Mobile, United States, 36608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Tallahassee, United States, 32308 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación MOL, Belgium, 2400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación GILLY, Belgium, 6060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Vaasa, Finland, 65130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Tampere, Finland, FIN-33520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Canton, United States, 44710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Buffalo, United States, 14215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Miramar, United States, 33025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Sacramento, United States, 95819 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Doylestown, United States, 18901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Wausau, United States, 54401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación National City, United States, 91950 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación El Cajon, United States, 92020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Montreal, Canada, H2W 1T8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Rockford, United States, 61107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Scottsdale, United States, 85258 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Nürnberg, Germany, 90471 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Leipzig, Germany, 04289 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Toledo, United States, 43623 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Albuquerque, United States, 87102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Stamford, United States, 06905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Butler, United States, 16001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Helsinki, Finland, FIN-00260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Victoria, Canada, V8R 4R2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Layton, United States, 84041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Cleveland, United States, 44195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Tyler, United States, 75701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Clearwater, United States, 33756 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Deltona, United States, 32725 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Ft. Lauderdale, United States, 33316 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Bridgewater, United States, 08807 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Daytona Beach, United States, 32117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Fort Sam Houston, United States, 78234-6200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Wilmington, United States, 19803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Philadelphia, United States, 19141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Annapolis, United States, 21401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Beijing, China, 100029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Xi'an, China, 710061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Orlando, United States, 32806 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Shenyang, China, 110016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Wuhan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Urumqi, China, 830054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Guangzhou, China, 510080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Nanchang, China, 330006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Changchun, China, 130021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Torrance, United States, 90502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Troy, United States, 12180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Manalapan, United States, 07716 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Austin, United States, 78745 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación New Haven, United States, 06520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Melbourne, United States, 32901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación St. Augustine, United States, 32086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Jacksonville, United States, 32216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Joliet, United States, 60435 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación TOURS, France, 37044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación PARIS, France, 75012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Ubicaciones Centro de investigación St. John's, Canada, A1B 3V6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Diseño del ensayo
A prospective, randomized, open-label, parallel-group, active-controlled, multicenter study exploring the efficacy and safety of once-daily oral rivaroxaban (BAY59-7939) compared with that of dose-adjusted oral vitamin K antagonists (VKA) for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of participants with composite of the following events, adjudicated centrally: stroke, transient ischemic attack, non-central nervous system systemic embolism, myocardial infarction and cardiovascular deathStroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with major bleedings as per central adjudicationBleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.Timeframe: From randomization up to the date of the last dose of study drug + 2 days
Secondary Outcome
- Number of participants with composite of strokes and non-central nervous system systemic embolismsStroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with composite of strokes, transient ischemic attacks, non-central nervous system systemic embolisms, myocardial infarctions and all-cause mortalityStroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with strokesAll events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with transient ischemic attacksAll events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with non-central nervous system systemic embolismsAll events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with myocardial infarctionsAll events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with cardiovascular deathsAll events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with all-cause mortalityAll events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- Number of participants with composite of major and non-major bleeding eventsAll events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.Timeframe: From randomization up to the date of the last dose of study drug + 2 days
Información adicional
Copyright © Bayer
Promovido por
