ID

25846

Beskrivning

Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation; ODM derived from: https://clinicaltrials.gov/show/NCT00691470

Länk

https://clinicaltrials.gov/show/NCT00691470

Nyckelord

Versioner (1)
  1. 2017-09-21 2017-09-21 -
Uppladdad den

21 september 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00691470

Engelsk

Eligibility Atrial Fibrillation NCT00691470

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with one or more of the following indications for chronic warfarin anticoagulation (the patient may either be a new candidate for anticoagulation or may already be receiving warfarin):
Beskrivning

Indication Warfarin Anticoagulation chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0043031
UMLS CUI [1,3]
C0003281
UMLS CUI [1,4]
C0205191
1. atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ecg) or atrial flutter.
Beskrivning

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Cause Reversible Absent Electrocardiography | Atrial Flutter

Datatyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0205343
UMLS CUI [4,3]
C0332197
UMLS CUI [4,4]
C1623258
UMLS CUI [5]
C0004239
2. a prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation.
Beskrivning

Heart Valve Prosthesis Position Aortic | Mitral valve prosthesis | Anticoagulation chronic Patient need for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018825
UMLS CUI [1,2]
C0733755
UMLS CUI [1,3]
C0003483
UMLS CUI [2]
C0182494
UMLS CUI [3,1]
C0003281
UMLS CUI [3,2]
C0205191
UMLS CUI [3,3]
C0686904
3. a history of venous thromboembolic disease (dvt and/or pe) requiring long term anticoagulation (> 6 months).
Beskrivning

Thromboembolism of vein | Deep Vein Thrombosis | Pulmonary Embolism | Anticoagulation Therapy Long-term Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C1997614
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
UMLS CUI [4,1]
C0003281
UMLS CUI [4,2]
C0443252
UMLS CUI [4,3]
C0686904
4. a history of myocardial infarction or cardiomyopathy requiring anticoagulation.
Beskrivning

Myocardial Infarction | Cardiomyopathy Requirement Anticoagulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003281
5. currently receiving chronic warfarin therapy for another indication not listed, with sponsor approval.
Beskrivning

Warfarin chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0205191
2. male or female greater than 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. able and willing to sign irb approved written informed consent to participate in the study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. contraindications to anticoagulation as listed in the warfarin package insert (appendix d), such as active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral av malformations, cerebral or aortic aneurysms, pericarditis or endocarditis. patients who have had recent (< 14 days from screening) surgery or invasive procedures or are about to undergo surgery or other invasive procedures, such as lumbar puncture. patients with blood dyscrasias or inherited disorders of hemostasis. patients with a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum, or gastrointestinal tract.
Beskrivning

Medical contraindication Anticoagulation | Hemorrhage | Lesion Associated with Bleeding Risk | Gastric ulcer | COLON AV MALFORMATION | Arteriovenous Malformations, Cerebral | Cerebral Aneurysm | Aortic Aneurysm | Pericarditis | Endocarditis | Operative Surgical Procedures | Invasive procedure | Spinal Puncture | Hematological Disease | Blood Coagulation Disorders Hereditary | Bleeding tendency | Hemorrhagic Disorders Serious | hemorrhage; cranial | Eye Hemorrhage | Hematomyelia | Retroperitoneal hemorrhage | Gastrointestinal Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [2]
C0019080
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C3251812
UMLS CUI [4]
C0038358
UMLS CUI [5]
C0742579
UMLS CUI [6]
C0917804
UMLS CUI [7]
C0917996
UMLS CUI [8]
C0003486
UMLS CUI [9]
C0031046
UMLS CUI [10]
C0014118
UMLS CUI [11]
C0543467
UMLS CUI [12]
C4048276
UMLS CUI [13]
C0037943
UMLS CUI [14]
C0018939
UMLS CUI [15,1]
C0005779
UMLS CUI [15,2]
C0439660
UMLS CUI [16]
C1458140
UMLS CUI [17,1]
C0019087
UMLS CUI [17,2]
C0205404
UMLS CUI [18]
C1390140
UMLS CUI [19]
C0015402
UMLS CUI [20]
C0018949
UMLS CUI [21]
C0151705
UMLS CUI [22]
C0017181
2. laboratory evidence at screening of clinically significant active bleeding, such as unexplained positive occult blood in stool, or unexplained positive urinary blood that is more than trace positive for hemoglobin.
Beskrivning

Hemorrhage | Positive fecal occult blood without explanation | Hematuria without explanation | Hemoglobin trace positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2,1]
C0266813
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0681841
UMLS CUI [3,1]
C0221752
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0681841
UMLS CUI [4,1]
C0019046
UMLS CUI [4,2]
C0442822
UMLS CUI [4,3]
C1514241
3. concomitant use of other anticoagulant or antiplatelet agents that may add to the hemostatic burden such as clopidogrel, ticlopidine, heparin or low molecular weight heparin (lmwh), or regular use of non selective long acting nsaids that cannot be discontinued prior to initiating ati 5923/warfarin dosing (daily use of 81-100 mg aspirin is allowed).
Beskrivning

Anticoagulants | Antiplatelet Agents | Involvement with Hemostatic function | clopidogrel | Ticlopidine | Heparin | Heparin, Low-Molecular-Weight | Non-Steroidal Anti-Inflammatory Agents Long-term Active | ATI 5923 Dosage | Warfarin Dosage | Aspirin Dose allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0085826
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0019116
UMLS CUI [4]
C0070166
UMLS CUI [5]
C0040207
UMLS CUI [6]
C0019134
UMLS CUI [7]
C0019139
UMLS CUI [8,1]
C0003211
UMLS CUI [8,2]
C0443252
UMLS CUI [8,3]
C0205177
UMLS CUI [9,1]
C2932027
UMLS CUI [9,2]
C0178602
UMLS CUI [10,1]
C0043031
UMLS CUI [10,2]
C0178602
UMLS CUI [11,1]
C0004057
UMLS CUI [11,2]
C0178602
UMLS CUI [11,3]
C0683607
4. a life expectancy of < 1 year, end stage renal failure requiring dialysis, end stage pulmonary disease requiring home oxygen, severe heart failure (nyha class iv).
Beskrivning

Life Expectancy | Chronic Kidney Failure Requirement Dialysis | End-stage Lung disease Requirement Home oxygen | Heart failure Severe New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0022661
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0011946
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205088
UMLS CUI [3,3]
C1514873
UMLS CUI [3,4]
C0421203
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1275491
5. dementia, severe psychiatric disorder, or ongoing alcohol or substance abuse.
Beskrivning

Dementia | Mental Disorders, Severe | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C4046029
UMLS CUI [3]
C0038586
6. laboratory screening values indicating severe anemia (hb < 10 gm/l), thrombocytopenia (platelet count < 90,000/mcl), or active liver disease.
Beskrivning

Laboratory Results | Anemia, severe | Hemoglobin measurement | Thrombocytopenia | Platelet Count measurement | Liver diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0238644
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0040034
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0023895
7. patients with conditions that will interfere with determination of the inr using the inratio device, i.e., hematocrit <30% or >55%. patients with the antiphospholipid syndrome may have abnormal inr results and should not be enrolled.
Beskrivning

Condition Interferes with INR Determination | Hematocrit level | Antiphospholipid Syndrome | INR abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525032
UMLS CUI [1,4]
C1148554
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0085278
UMLS CUI [4]
C0580417
8. history of non disabling ischemic stroke within the last 3 months, prior major disabling ischemic stroke, or any history of intracranial bleeding.
Beskrivning

Ischemic stroke | Ischemic stroke disabling major | Intracranial Hemorrhages

Datatyp

boolean

Alias
UMLS CUI [1]
C0948008
UMLS CUI [2,1]
C0948008
UMLS CUI [2,2]
C0596452
UMLS CUI [2,3]
C0205164
UMLS CUI [3]
C0151699
9. pregnant or nursing women or women of childbearing potential who will not use adequate contraception, such as oral or implantable contraceptives, iud, or barrier methods (iud or condom) with spermicide.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Contraceptives, Oral | implantable contraceptive capsules | Intrauterine Devices | Contraception, Barrier | Female Condoms | Vaginal Spermicides

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
UMLS CUI [4]
C0009905
UMLS CUI [5]
C2048401
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0004764
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0087145
10. currently participating in another clinical trial at screening, treatment with an investigational drug within 30 days of the first dose of study medication, or patients who previously participated in an ati-5923 trial.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Atrial Fibrillation NCT00691470

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Warfarin Anticoagulation chronic
Item
1. patients with one or more of the following indications for chronic warfarin anticoagulation (the patient may either be a new candidate for anticoagulation or may already be receiving warfarin):
boolean
C3146298 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Cause Reversible Absent Electrocardiography | Atrial Flutter
Item
1. atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ecg) or atrial flutter.
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0015127 (UMLS CUI [4,1])
C0205343 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1623258 (UMLS CUI [4,4])
C0004239 (UMLS CUI [5])
Heart Valve Prosthesis Position Aortic | Mitral valve prosthesis | Anticoagulation chronic Patient need for
Item
2. a prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation.
boolean
C0018825 (UMLS CUI [1,1])
C0733755 (UMLS CUI [1,2])
C0003483 (UMLS CUI [1,3])
C0182494 (UMLS CUI [2])
C0003281 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Thromboembolism of vein | Deep Vein Thrombosis | Pulmonary Embolism | Anticoagulation Therapy Long-term Patient need for
Item
3. a history of venous thromboembolic disease (dvt and/or pe) requiring long term anticoagulation (> 6 months).
boolean
C1997614 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0003281 (UMLS CUI [4,1])
C0443252 (UMLS CUI [4,2])
C0686904 (UMLS CUI [4,3])
Myocardial Infarction | Cardiomyopathy Requirement Anticoagulation
Item
4. a history of myocardial infarction or cardiomyopathy requiring anticoagulation.
boolean
C0027051 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003281 (UMLS CUI [2,3])
Warfarin chronic
Item
5. currently receiving chronic warfarin therapy for another indication not listed, with sponsor approval.
boolean
C0043031 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Age
Item
2. male or female greater than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. able and willing to sign irb approved written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
4. able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Anticoagulation | Hemorrhage | Lesion Associated with Bleeding Risk | Gastric ulcer | COLON AV MALFORMATION | Arteriovenous Malformations, Cerebral | Cerebral Aneurysm | Aortic Aneurysm | Pericarditis | Endocarditis | Operative Surgical Procedures | Invasive procedure | Spinal Puncture | Hematological Disease | Blood Coagulation Disorders Hereditary | Bleeding tendency | Hemorrhagic Disorders Serious | hemorrhage; cranial | Eye Hemorrhage | Hematomyelia | Retroperitoneal hemorrhage | Gastrointestinal Hemorrhage
Item
1. contraindications to anticoagulation as listed in the warfarin package insert (appendix d), such as active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral av malformations, cerebral or aortic aneurysms, pericarditis or endocarditis. patients who have had recent (< 14 days from screening) surgery or invasive procedures or are about to undergo surgery or other invasive procedures, such as lumbar puncture. patients with blood dyscrasias or inherited disorders of hemostasis. patients with a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum, or gastrointestinal tract.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C3251812 (UMLS CUI [3,3])
C0038358 (UMLS CUI [4])
C0742579 (UMLS CUI [5])
C0917804 (UMLS CUI [6])
C0917996 (UMLS CUI [7])
C0003486 (UMLS CUI [8])
C0031046 (UMLS CUI [9])
C0014118 (UMLS CUI [10])
C0543467 (UMLS CUI [11])
C4048276 (UMLS CUI [12])
C0037943 (UMLS CUI [13])
C0018939 (UMLS CUI [14])
C0005779 (UMLS CUI [15,1])
C0439660 (UMLS CUI [15,2])
C1458140 (UMLS CUI [16])
C0019087 (UMLS CUI [17,1])
C0205404 (UMLS CUI [17,2])
C1390140 (UMLS CUI [18])
C0015402 (UMLS CUI [19])
C0018949 (UMLS CUI [20])
C0151705 (UMLS CUI [21])
C0017181 (UMLS CUI [22])
Hemorrhage | Positive fecal occult blood without explanation | Hematuria without explanation | Hemoglobin trace positive
Item
2. laboratory evidence at screening of clinically significant active bleeding, such as unexplained positive occult blood in stool, or unexplained positive urinary blood that is more than trace positive for hemoglobin.
boolean
C0019080 (UMLS CUI [1])
C0266813 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0681841 (UMLS CUI [2,3])
C0221752 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0681841 (UMLS CUI [3,3])
C0019046 (UMLS CUI [4,1])
C0442822 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Anticoagulants | Antiplatelet Agents | Involvement with Hemostatic function | clopidogrel | Ticlopidine | Heparin | Heparin, Low-Molecular-Weight | Non-Steroidal Anti-Inflammatory Agents Long-term Active | ATI 5923 Dosage | Warfarin Dosage | Aspirin Dose allowed
Item
3. concomitant use of other anticoagulant or antiplatelet agents that may add to the hemostatic burden such as clopidogrel, ticlopidine, heparin or low molecular weight heparin (lmwh), or regular use of non selective long acting nsaids that cannot be discontinued prior to initiating ati 5923/warfarin dosing (daily use of 81-100 mg aspirin is allowed).
boolean
C0003280 (UMLS CUI [1])
C0085826 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0019116 (UMLS CUI [3,2])
C0070166 (UMLS CUI [4])
C0040207 (UMLS CUI [5])
C0019134 (UMLS CUI [6])
C0019139 (UMLS CUI [7])
C0003211 (UMLS CUI [8,1])
C0443252 (UMLS CUI [8,2])
C0205177 (UMLS CUI [8,3])
C2932027 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0043031 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0004057 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0683607 (UMLS CUI [11,3])
Life Expectancy | Chronic Kidney Failure Requirement Dialysis | End-stage Lung disease Requirement Home oxygen | Heart failure Severe New York Heart Association Classification
Item
4. a life expectancy of < 1 year, end stage renal failure requiring dialysis, end stage pulmonary disease requiring home oxygen, severe heart failure (nyha class iv).
boolean
C0023671 (UMLS CUI [1])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
C0024115 (UMLS CUI [3,1])
C0205088 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0421203 (UMLS CUI [3,4])
C0018801 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
Dementia | Mental Disorders, Severe | Substance Use Disorders
Item
5. dementia, severe psychiatric disorder, or ongoing alcohol or substance abuse.
boolean
C0497327 (UMLS CUI [1])
C4046029 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Laboratory Results | Anemia, severe | Hemoglobin measurement | Thrombocytopenia | Platelet Count measurement | Liver diseases
Item
6. laboratory screening values indicating severe anemia (hb < 10 gm/l), thrombocytopenia (platelet count < 90,000/mcl), or active liver disease.
boolean
C1254595 (UMLS CUI [1])
C0238644 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0040034 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
Condition Interferes with INR Determination | Hematocrit level | Antiphospholipid Syndrome | INR abnormal
Item
7. patients with conditions that will interfere with determination of the inr using the inratio device, i.e., hematocrit <30% or >55%. patients with the antiphospholipid syndrome may have abnormal inr results and should not be enrolled.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525032 (UMLS CUI [1,3])
C1148554 (UMLS CUI [1,4])
C0518014 (UMLS CUI [2])
C0085278 (UMLS CUI [3])
C0580417 (UMLS CUI [4])
Ischemic stroke | Ischemic stroke disabling major | Intracranial Hemorrhages
Item
8. history of non disabling ischemic stroke within the last 3 months, prior major disabling ischemic stroke, or any history of intracranial bleeding.
boolean
C0948008 (UMLS CUI [1])
C0948008 (UMLS CUI [2,1])
C0596452 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0151699 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Contraceptives, Oral | implantable contraceptive capsules | Intrauterine Devices | Contraception, Barrier | Female Condoms | Vaginal Spermicides
Item
9. pregnant or nursing women or women of childbearing potential who will not use adequate contraception, such as oral or implantable contraceptives, iud, or barrier methods (iud or condom) with spermicide.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C2048401 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
Study Subject Participation Status | Investigational New Drugs
Item
10. currently participating in another clinical trial at screening, treatment with an investigational drug within 30 days of the first dose of study medication, or patients who previously participated in an ati-5923 trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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