BIBR 1048 | Therapeutic procedure Discontinuation Early Absent
Item
previous treatment with bibr 1048 in petro (trial 1160.20- nct01227629) and no premature discontinuation of therapy
boolean
C1122231 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1279919 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Non-rheumatic atrial fibrillation chronic | Electrocardiography
Item
paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ecg) at least twice prior to enrollment in petro
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0340490 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C1623258 (UMLS CUI [5])
Coronary Artery Disease At risk Cerebrovascular accident | Hypertensive disease | Diabetes Mellitus | Congestive heart failure | Ventricular Dysfunction, Left | Ischemic stroke | Transient Ischemic Attack | Age
Item
concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (dm), congestive heart failure (chf) or left ventricular dysfunction (lvd), previous ischemic stroke or transient ischemic attack) tia, or age greater than 75 years. -age >= 18 years
boolean
C1956346 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0020538 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0242698 (UMLS CUI [5])
C0948008 (UMLS CUI [6])
C0007787 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
Informed consent
Item
written, informed consent
boolean
C0021430 (UMLS CUI [1])
Heart valve disease High risk of Thromboembolism | Mitral Valve Stenosis Clinical Significance | Prosthetic valve | Electric Countershock Planned
Item
valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study.
boolean
C0018824 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0040038 (UMLS CUI [1,3])
C0026269 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0336548 (UMLS CUI [3])
C0013778 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Medical contraindication Anticoagulant therapy | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Hemorrhage Severe | Warfarin | International Normalized Ratio Therapeutic | Anti-Inflammatory Agents, Non-Steroidal | Hemorrhagic Disorders | Hemorrhage Major
Item
contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (gi) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (inr), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than gi hemorrhage).
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0151699 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0019080 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0043031 (UMLS CUI [5])
C0525032 (UMLS CUI [6,1])
C0302350 (UMLS CUI [6,2])
C0003211 (UMLS CUI [7])
C0019087 (UMLS CUI [8])
C0019080 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
severe renal impairment (estimated glomerular filtration rate [gfr] <= 30 ml/min). uncontrolled hypertension (systolic blood pressure [sbp] > 180 mm hg and/or diastolic blood pressure [dbp] > 100 mmhg).
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Pregnancy | Childbearing Potential | Contraceptive methods Refused | Pregnancy test negative
Item
women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0427780 (UMLS CUI [4])
Investigational New Drugs | BIBR 1048
Item
patients who have received an investigational drug other than bibr 1048 within the last 30 days.
boolean
C0013230 (UMLS CUI [1])
C1122231 (UMLS CUI [2])
Compliance behavior Limited | Medical contraindication Anticoagulant therapy | Deep Vein Thrombosis | Pulmonary Embolism | Anemia Clinical Significance | ANEMIA, MILD OR MODERATE | Gastrointestinal Hemorrhage | Thrombocytopenia | Platelet Count measurement | Study Subject Participation Status Limited
Item
patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a gi bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). patients suffering from thrombocytopenia (platelets < 100,000/ul). any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0150457 (UMLS CUI [2,2])
C0149871 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
C0002871 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0238643 (UMLS CUI [6])
C0017181 (UMLS CUI [7])
C0040034 (UMLS CUI [8])
C0032181 (UMLS CUI [9])
C2348568 (UMLS CUI [10,1])
C0439801 (UMLS CUI [10,2])
Antiplatelet Agents | Aspirin
Item
continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (asa).
boolean
C0085826 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
Malignant Neoplasms | Therapeutic radiology procedure
Item
recent malignancy or radiation therapy (<= 6 months).
boolean
C0006826 (UMLS CUI [1])
C1522449 (UMLS CUI [2])