ID

44406

Beschreibung

Clarification of Optimal Anticoagulation Through Genetics; ODM derived from: https://clinicaltrials.gov/show/NCT00839657

Link

https://clinicaltrials.gov/show/NCT00839657

Stichworte

Versionen (2)
  1. 04.11.18 04.11.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Stroke NCT00839657

Englisch

Eligibility Stroke NCT00839657

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT00839657
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
willingness and ability to sign informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
able to be followed in outpatient ac clinic
Beschreibung

Ability Follow-up Outpatient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C0029921
expected duration of warfarin therapy of at least 1 month
Beschreibung

Warfarin | Duration of therapy Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C0444921
UMLS CUI [2,2]
C1517001
ac management for the patient will be performed in-hospital and as an outpatient by clinicians that will adhere to the study dosing algorithms and dose titration plans
Beschreibung

Inpatient | Outpatient | Adherence Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
UMLS CUI [3,1]
C1510802
UMLS CUI [3,2]
C2348563
target inr 2-3
Beschreibung

Target INR

Datentyp

boolean

Alias
UMLS CUI [1]
C1272307
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently taking warfarin
Beschreibung

Warfarin

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
prior warfarin therapy with known required stable dose
Beschreibung

Warfarin | Prior Therapy Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
clinician opinion that warfarin dosing needs to be adjusted for reasons not accounted for by dosing algorithm
Beschreibung

Warfarin | Dose Adjustment Required

Datentyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2,1]
C2826232
UMLS CUI [2,2]
C1514873
abnormal baseline inr (off warfarin) (e.g., due to liver disease, antiphospholipid antibody)
Beschreibung

INR abnormal | Etiology Liver disease | Etiology Antiphospholipid Antibody

Datentyp

boolean

Alias
UMLS CUI [1]
C0580417
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0023895
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0162595
contraindication to warfarin treatment for at least 3 months
Beschreibung

Medical contraindication Warfarin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
life expectancy of less than 1 year
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
pregnant women or child-bearing women not using medically approved method of birth control (requires negative pregnancy test to exclude pregnancy in child-bearing women)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
inability to follow-up on a regular basis with anticoagulation practitioners participating in the trial
Beschreibung

Follow-up Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
any factors likely to limit adherence to warfarin
Beschreibung

Factor Limiting Adherence Warfarin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C0043031
cognitive or other causes of inability to provide informed consent or follow study procedures
Beschreibung

Impaired cognition Informed Consent Unable | Impaired cognition Protocol Compliance Unable | Cause Informed Consent Unable | Cause Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0338656
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0525058
UMLS CUI [4,3]
C1299582
participating in another trial that prohibits participation in the coag trial or planned enrollment in such a trial within the first 6 months of warfarin therapy
Beschreibung

Study Subject Participation Status | Exclusion Participation Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205369
estimated blood loss of more than 1,000 cc requiring blood transfusions within 48 hours prior to randomization
Beschreibung

Blood Loss Amount | Blood Transfusion Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C1514873
genotype (cyp2c9 or vkorc1) known to participant from prior testing
Beschreibung

Study Subject Participation Status | CYP2C9 Genotype | VKORC1 Genotype

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1332829
UMLS CUI [2,2]
C0017431
UMLS CUI [3,1]
C1428184
UMLS CUI [3,2]
C0017431
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Ähnliche Modelle

Eligibility Stroke NCT00839657

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Stroke NCT00839657
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willingness and ability to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Ability Follow-up Outpatient
Item
able to be followed in outpatient ac clinic
boolean
C0085732 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0029921 (UMLS CUI [1,3])
Warfarin | Duration of therapy Expected
Item
expected duration of warfarin therapy of at least 1 month
boolean
C0043031 (UMLS CUI [1])
C0444921 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Inpatient | Outpatient | Adherence Study Protocol
Item
ac management for the patient will be performed in-hospital and as an outpatient by clinicians that will adhere to the study dosing algorithms and dose titration plans
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C1510802 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
Target INR
Item
target inr 2-3
boolean
C1272307 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Warfarin
Item
currently taking warfarin
boolean
C0043031 (UMLS CUI [1])
Warfarin | Prior Therapy Dose Stable
Item
prior warfarin therapy with known required stable dose
boolean
C0043031 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Warfarin | Dose Adjustment Required
Item
clinician opinion that warfarin dosing needs to be adjusted for reasons not accounted for by dosing algorithm
boolean
C0043031 (UMLS CUI [1])
C2826232 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
INR abnormal | Etiology Liver disease | Etiology Antiphospholipid Antibody
Item
abnormal baseline inr (off warfarin) (e.g., due to liver disease, antiphospholipid antibody)
boolean
C0580417 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0023895 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0162595 (UMLS CUI [3,2])
Medical contraindication Warfarin
Item
contraindication to warfarin treatment for at least 3 months
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of less than 1 year
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy test negative
Item
pregnant women or child-bearing women not using medically approved method of birth control (requires negative pregnancy test to exclude pregnancy in child-bearing women)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Follow-up Unable
Item
inability to follow-up on a regular basis with anticoagulation practitioners participating in the trial
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Factor Limiting Adherence Warfarin
Item
any factors likely to limit adherence to warfarin
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C0043031 (UMLS CUI [1,4])
Impaired cognition Informed Consent Unable | Impaired cognition Protocol Compliance Unable | Cause Informed Consent Unable | Cause Protocol Compliance Unable
Item
cognitive or other causes of inability to provide informed consent or follow study procedures
boolean
C0338656 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0525058 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Study Subject Participation Status | Exclusion Participation Clinical Trial Specified
Item
participating in another trial that prohibits participation in the coag trial or planned enrollment in such a trial within the first 6 months of warfarin therapy
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205369 (UMLS CUI [2,4])
Blood Loss Amount | Blood Transfusion Required
Item
estimated blood loss of more than 1,000 cc requiring blood transfusions within 48 hours prior to randomization
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0005841 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Study Subject Participation Status | CYP2C9 Genotype | VKORC1 Genotype
Item
genotype (cyp2c9 or vkorc1) known to participant from prior testing
boolean
C2348568 (UMLS CUI [1])
C1332829 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1428184 (UMLS CUI [3,1])
C0017431 (UMLS CUI [3,2])
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