ID

16147

Description

Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048; ODM derived from: https://clinicaltrials.gov/show/NCT00157248

Lien

https://clinicaltrials.gov/show/NCT00157248

Mots-clés

Versions (1)
  1. 02/07/2016 02/07/2016 -
Téléchargé le

2 juillet 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00157248

Anglais

Eligibility Atrial Fibrillation NCT00157248

1 Formulaires  
Criteria
Description

Criteria

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous treatment with bibr 1048 in petro (trial 1160.20- nct01227629) and no premature discontinuation of therapy
Description

BIBR 1048 | Therapeutic procedure Discontinuation Early Absent

Type de données

boolean

Alias
UMLS CUI [1]
C1122231
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1279919
UMLS CUI [2,4]
C0332197
paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ecg) at least twice prior to enrollment in petro
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Non-rheumatic atrial fibrillation chronic | Electrocardiography

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
UMLS CUI [4,1]
C0340490
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C1623258
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
Description

Coronary Artery Disease At risk Cerebrovascular accident | Hypertensive disease | Diabetes Mellitus | Congestive heart failure | Ventricular Dysfunction, Left | Ischemic stroke | Transient Ischemic Attack | Age

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0038454
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0242698
UMLS CUI [6]
C0948008
UMLS CUI [7]
C0007787
UMLS CUI [8]
C0001779
written, informed consent
Description

Informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

Heart valve disease High risk of Thromboembolism | Mitral Valve Stenosis Clinical Significance | Prosthetic valve | Electric Countershock Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0040038
UMLS CUI [2,1]
C0026269
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C0336548
UMLS CUI [4,1]
C0013778
UMLS CUI [4,2]
C1301732
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).
Description

Medical contraindication Anticoagulant therapy | Intracranial Hemorrhages | Gastrointestinal Hemorrhage | Hemorrhage Severe | Warfarin | International Normalized Ratio Therapeutic | Anti-Inflammatory Agents, Non-Steroidal | Hemorrhagic Disorders | Hemorrhage Major

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
UMLS CUI [2]
C0151699
UMLS CUI [3]
C0017181
UMLS CUI [4,1]
C0019080
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0043031
UMLS CUI [6,1]
C0525032
UMLS CUI [6,2]
C0302350
UMLS CUI [7]
C0003211
UMLS CUI [8]
C0019087
UMLS CUI [9,1]
C0019080
UMLS CUI [9,2]
C0205164
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).
Description

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
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).
Description

Pregnancy | Childbearing Potential | Contraceptive methods Refused | Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1705116
UMLS CUI [4]
C0427780
patients who have received an investigational drug other than bibr 1048 within the last 30 days.
Description

Investigational New Drugs | BIBR 1048

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1122231
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.
Description

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0150457
UMLS CUI [3]
C0149871
UMLS CUI [4]
C0034065
UMLS CUI [5,1]
C0002871
UMLS CUI [5,2]
C2826293
UMLS CUI [6]
C0238643
UMLS CUI [7]
C0017181
UMLS CUI [8]
C0040034
UMLS CUI [9]
C0032181
UMLS CUI [10,1]
C2348568
UMLS CUI [10,2]
C0439801
continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (asa).
Description

Antiplatelet Agents | Aspirin

Type de données

boolean

Alias
UMLS CUI [1]
C0085826
UMLS CUI [2]
C0004057
recent malignancy or radiation therapy (<= 6 months).
Description

Malignant Neoplasms | Therapeutic radiology procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1522449
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Similar models

Eligibility Atrial Fibrillation NCT00157248

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
Item Group
C0680251 (UMLS CUI)
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])
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