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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003890-40 | EudraCT Number |
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The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.
Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.
It is not intended to assess confirmatory hypothesis, this is an exploratory study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran Etexilate 150mg | Experimental | Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) |
|
| Warfarin | Active Comparator | Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) | Major bleeds were defined according to the ISTH definition of a major bleed, as follows
These are based on adjudicated data (blinded evaluation) Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented. | during and up to 2 months post-ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA) | Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. These are based on adjudicated data (blinded evaluation). Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented |
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Inclusion criteria:
Exclusion criteria:
Patients with permanent AF.
Patients with AF felt to be secondary to an obvious reversible cause such as, but not limited to, an acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis.
Patients with Left Atrium (LA) size >= 60 mm
Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate
Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients
Mechanical or biological heart valve prosthesis
Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
Stroke within 1 month prior to screening visit
Major surgery per investigator judgement within the previous month prior to screening.
Patient has received an organ transplant or is on a waiting list for an organ transplant
History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding
Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery).
Major bleeding episode (ISTH definition) one month prior to the screening visit.
Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention)
Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 10^9/L) at screening
Recent malignancy or radiation therapy (<=6 months prior to screening) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
Active liver disease as indicated by at least one of the following:
-- Prior and persistent alanine aminotransferase or Aspartate transaminase or alkaline phosphatase >3x upper limit of normal and/or -- Known active hepatitis C and/or -- Known active hepatitis B and/or -- Known active hepatitis A
Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic/myelosuppressive therapy.
Pre-menopausal (last menstruation <=1 year prior to screening) who:
Patients who have participated in another trial with an investigational drug or device within the past 30 days preceding the screening visit or are participating in another trial (patients participating in an observational study only will not be excluded)
Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease and/or subjects who are institutionalised due to official or court orders and/or vulnerable subjects who are dependent on the Sponsor or the Investigator or the site, or patients who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse).
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Cardiology, PA | Little Rock | Arkansas | 72205 | United States | ||
| Mission Cardiovascular Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33509678 | Derived | Kimata A, Nogami A, Yamasaki H, Ohigashi T, Gosho M, Igarashi M, Sekiguchi Y, Ieda M, Calkins H, Aonuma K. Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials. J Cardiol. 2021 Jun;77(6):652-659. doi: 10.1016/j.jjcc.2020.12.010. Epub 2021 Jan 25. | |
| 30758702 |
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Patients were randomly assigned to dabigatran etexilate 150 mg twice daily or warfarin in a 1:1 ratio and remained on this treatment for the duration of the trial. 678 subjects were randomised and 676 were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate 150 mg | Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID); 1 capsule 150 mg twice daily (total daily dose 300 mg) |
| FG001 | Warfarin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dabigatran Etexilate 150mg | Drug | Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) |
|
| during and up to 2 months post-ablation |
| Incidence of Minor Bleeding Events | Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented. These are based on adjudicated data (blinded evaluation) | during and up to 2 months post-ablation |
| Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy | Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented. These are based on adjudicated data (blinded evaluation) | during and up to 2 months post-ablation |
| Fremont |
| California |
| 94538 |
| United States |
| University of California | Sacramento | California | 95817 | United States |
| Mercy Medical Group, a service of Dignity Health Medical Foundation | Sacramento | California | 95819 | United States |
| University of California | San Francisco | California | 94143 | United States |
| Southwest Florida Research, LLC | Naples | Florida | 34102 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Elkhart General Healthcare System | Elkhart | Indiana | 46514 | United States |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| St. Louis Heart and Vascular, P.C. | St Louis | Missouri | 63136 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| University at Buffalo, The State University of New York | Buffalo | New York | 14203 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104-5068 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Tennessee Methodist Physicians | Memphis | Tennessee | 38104 | United States |
| North Texas Heart Center | Dallas | Texas | 75231 | United States |
| St Luke's Health Baylor College of Medicine Med Center | Houston | Texas | 77030 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| Bonheiden - HOSP Imelda | Bonheiden | 2820 | Belgium |
| Brussels - UNIV UZ Brussel | Brussels | 1090 | Belgium |
| UNIV UZ Gent | Ghent | 9000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Antwerpen - HOSP ZNA Middelheim - Pneumo | Middelheim | 2020 | Belgium |
| Brussels - HOSP Europe (Ste-Elisabeth) | Uccle | 1180 | Belgium |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Victoria Cardiac Arrhythmia Trials Inc. | Victoria | British Columbia | V8T 1Z4 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| CHUS Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| IUCPQ (Laval University) | Québec | G1V 4G5 | Canada |
| HOP Nord Michallon | La Tronche | 38700 | France |
| HOP Timone | Marseille | 13005 | France |
| CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2 | Nantes | 44000 | France |
| HOP Salpêtrière, Cardio, Paris | Paris | 75013 | France |
| HOP Européen G. Pompidou | Paris | 75015 | France |
| HOP Haut-Lévêque | Pessac | 33604 | France |
| HOP CHU Nancy Brabois, Cardiologie | Vandœuvre-lès-Nancy | 54511 | France |
| Vivantes Netzwerk für Gesundheit GmbH | Berlin | 10967 | Germany |
| Universitätsklinikum Köln (AöR) | Cologne | 50937 | Germany |
| Universitätsmedizin Göttingen, Georg-August-Universität | Göttingen | 37075 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Ospedale Generale Regionale "Miulli" | Acquaviva Delle Fonti (BA) | 70021 | Italy |
| A.S.O.S. Croce e Carle | Cuneo | 12100 | Italy |
| Osp.dell'Angelo | Mestre-Venezia | 30174 | Italy |
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| Centro Cardiologico Monzino-IRCCS | Milan | 20138 | Italy |
| Policlinico Casilino U.O. Cardiologia | Roma | 00169 | Italy |
| Anjo-kosei Hospital | Aichi, Anjo | 446-8602 | Japan |
| Nagoya City East Medical Center | Aichi, Nagoya | 464-8547 | Japan |
| Nagoya University Hospital | Aichi, Nagoya | 466-8560 | Japan |
| Japanese Red Cross Nagoya Daini Hospital | Aichi, Nagoya | 466-8650 | Japan |
| Hirosaki University Hospital | Aomori, Hirosaki | 036-8563 | Japan |
| New Tokyo Heart Clinic | Chiba, Matsudo | 271-0077 | Japan |
| Shonan Kamakura General Hospital | Kanagawa, Kamakura | 247-8533 | Japan |
| Sakurabashi Watanabe Hospital | Osaka, Osaka | 530-0001 | Japan |
| Nippon Medical School Hospital | Tokyo, Bunkyo-Ku | 113-8603 | Japan |
| Tokyo Medical University Hachioji Medical Center | Tokyo, Hachioji | 193-0998 | Japan |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091AC | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Radboud Universitair Medisch Centrum | Nijmegen | 6525 GA | Netherlands |
| Heart&Vessels Diseases,Cardiol&Cardiovas.SurgeryDep,Kamerovo | Kemerovo | 650002 | Russia |
| Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep | Moscow | 117997 | Russia |
| North-Westrn Fed.med.res.cntr,Almazov Interven.arrhythmo.dep | Saint Petersburg | 197341 | Russia |
| City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg | Saint Petersburg | 199 106 | Russia |
| Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia | Tyumen | 625026 | Russia |
| Yaroslavl Regional Clin. Hospital, Dept. Endocrinology | Yaroslavl | 150062 | Russia |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Álvaro Cunqueiro | Vigo (Pontevedra) | 36312 | Spain |
| Royal Bournemouth and Christchurch Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Papworth Hospital | Cambridge | CB23 3RE | United Kingdom |
| Golden Jubilee National Hospital, Clydebank | Clydebank | G81 4DY | United Kingdom |
| Castle Hill Hopsital | Cottingham | HU16 5JQ | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 4NP | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Derived |
| Hohnloser SH, Calkins H, Willems S, Verma A, Schilling R, Okumura K, Nordaby M, Kleine E, Biss B, Gerstenfeld EP; RE-CIRCUIT(R) investigators. Regional differences in patient characteristics and outcomes during uninterrupted anticoagulation with dabigatran versus warfarin in catheter ablation of atrial fibrillation: the RE-CIRCUIT study. J Interv Card Electrophysiol. 2019 Aug;55(2):145-152. doi: 10.1007/s10840-019-00518-x. Epub 2019 Feb 13. |
| 28317415 | Derived | Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K, Biss B, Brouwer MA, Grimaldi M; RE-CIRCUIT Investigators. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017 Apr 27;376(17):1627-1636. doi: 10.1056/NEJMoa1701005. Epub 2017 Mar 19. |
Patients receiving Warfarin tablet orally;
1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range)
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): The treated set (TS) included all patients who were randomised and subsequently treated with at least 1 tablet/capsule.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate 150 mg | Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID); 1 capsule 150 mg twice daily (total daily dose 300 mg) |
| BG001 | Warfarin | Patients receiving Warfarin tablet orally; 1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) | Major bleeds were defined according to the ISTH definition of a major bleed, as follows
These are based on adjudicated data (blinded evaluation) Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented. | The ablation set (AS) was the primary analysis set and included all patients in the treated set (TS) who started the ablation procedure | Posted | Number | 95% Confidence Interval | percentage of participants | during and up to 2 months post-ablation |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA) | Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. These are based on adjudicated data (blinded evaluation). Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented | AS | Posted | Number | percentage of participants | during and up to 2 months post-ablation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Minor Bleeding Events | Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented. These are based on adjudicated data (blinded evaluation) | AS | Posted | Number | percentage of participants | during and up to 2 months post-ablation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy | Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented. These are based on adjudicated data (blinded evaluation) | AS | Posted | Number | percentage of participants | during and up to 2 months post-ablation |
|
|
All Adverse Events (AEs) which occurred after the first dose of trial medication up to 6 days after the last dose of trial medication; up to 225 days
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate 150 mg | Patients receiving Dabigatran Etexilate 150 mg capsule orally twice daily (BID); 1 capsule 150 mg twice daily (total daily dose 300 mg) | 63 | 338 | 68 | 338 | ||
| EG001 | Warfarin | Patients receiving Warfarin tablet orally; 1, 3, and 5 mg (dose adjusted to International normalized ratio (INR) target range) | 75 | 338 | 65 | 338 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial haemorrhage | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm ruptured | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Bleeding time prolonged | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Central nervous system neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral nerve paresis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Phrenic nerve paralysis | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|