ID

39488

Description

A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01877915

Link

https://clinicaltrials.gov/show/NCT01877915

Keywords

Versions (1)
  1. 1/17/20 1/17/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 17, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01877915

English

Eligibility Heart Failure NCT01877915

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have symptomatic heart failure for at least 3 months prior to screening
Description

Heart failure Symptomatic Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0872146
participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. an episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
Description

Episode of Decompensated cardiac failure | Requirement Hospital Stay Overnight | Medication administration: intravenous | Heart failure Patient observation | Parenteral therapy Heart failure Stabilization | Symptoms Dyspnea Worsening | Symptoms Fatigue | Signs Congestion | Peripheral edema | Ascites | Adjustment Heart failure Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0581377
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3489408
UMLS CUI [2,3]
C0439583
UMLS CUI [3]
C0812149
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0700325
UMLS CUI [5,1]
C0259961
UMLS CUI [5,2]
C0018801
UMLS CUI [5,3]
C1293130
UMLS CUI [6,1]
C1457887
UMLS CUI [6,2]
C0013404
UMLS CUI [6,3]
C0332271
UMLS CUI [7,1]
C1457887
UMLS CUI [7,2]
C0015672
UMLS CUI [8,1]
C0311392
UMLS CUI [8,2]
C0700148
UMLS CUI [9]
C0085649
UMLS CUI [10]
C0003962
UMLS CUI [11,1]
C0456081
UMLS CUI [11,2]
C0018801
UMLS CUI [11,3]
C0013227
must have a documented left ventricular ejection fraction (lvef) of less than or equal to 40 percent (%) within 1 year before randomization
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
must have evidence of significant coronary artery disease
Description

Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C1956346
must be medically stable in terms of their heart failure clinical status at the time of randomization
Description

Stable status Medical | Heart failure Clinical status

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0449440
must have a brain natriuretic peptide (bnp) level greater than or equal to (>=) 200 picogram per milliliter (pg/ml) or n-terminal-probnp (nt-probnp) level >=800 pg/ml (preferred assay) during the screening period and before randomization
Description

Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2]
C3272900
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
Description

Medical contraindication Anticoagulant therapy | Condition Associated with Bleeding risk | Internal hemorrhage | Hemorrhage Clinical Significance | Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C3251812
UMLS CUI [3]
C1390214
UMLS CUI [4,1]
C0019080
UMLS CUI [4,2]
C2826293
UMLS CUI [5]
C1458140
severe concomitant disease such as (a) atrial fibrillation (afib) or another condition that requires chronic anticoagulation (participants with isolated transient afib may be allowed at the discretion of the treating physician investigator) and (b) documented acute myocardial infarction (mi) during index event
Description

Comorbidity Severe | Atrial Fibrillation | Condition Requirement Chronic anticoagulation | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0004238
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0694554
UMLS CUI [4]
C0027051
prior stroke within 90 days of randomization
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
has been hospitalized for longer than 21 days during the index event
Description

Hospitalization Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Description

Inotropic agent Intravenous Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C1301732
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Similar models

Eligibility Heart Failure NCT01877915

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure Symptomatic Disease length
Item
must have symptomatic heart failure for at least 3 months prior to screening
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Episode of Decompensated cardiac failure | Requirement Hospital Stay Overnight | Medication administration: intravenous | Heart failure Patient observation | Parenteral therapy Heart failure Stabilization | Symptoms Dyspnea Worsening | Symptoms Fatigue | Signs Congestion | Peripheral edema | Ascites | Adjustment Heart failure Pharmaceutical Preparations
Item
participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. an episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
boolean
C0332189 (UMLS CUI [1,1])
C0581377 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3489408 (UMLS CUI [2,2])
C0439583 (UMLS CUI [2,3])
C0812149 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0700325 (UMLS CUI [4,2])
C0259961 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C1293130 (UMLS CUI [5,3])
C1457887 (UMLS CUI [6,1])
C0013404 (UMLS CUI [6,2])
C0332271 (UMLS CUI [6,3])
C1457887 (UMLS CUI [7,1])
C0015672 (UMLS CUI [7,2])
C0311392 (UMLS CUI [8,1])
C0700148 (UMLS CUI [8,2])
C0085649 (UMLS CUI [9])
C0003962 (UMLS CUI [10])
C0456081 (UMLS CUI [11,1])
C0018801 (UMLS CUI [11,2])
C0013227 (UMLS CUI [11,3])
Left ventricular ejection fraction
Item
must have a documented left ventricular ejection fraction (lvef) of less than or equal to 40 percent (%) within 1 year before randomization
boolean
C0428772 (UMLS CUI [1])
Coronary Artery Disease
Item
must have evidence of significant coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Stable status Medical | Heart failure Clinical status
Item
must be medically stable in terms of their heart failure clinical status at the time of randomization
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0449440 (UMLS CUI [2,2])
Brain natriuretic peptide measurement | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
must have a brain natriuretic peptide (bnp) level greater than or equal to (>=) 200 picogram per milliliter (pg/ml) or n-terminal-probnp (nt-probnp) level >=800 pg/ml (preferred assay) during the screening period and before randomization
boolean
C1095989 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Anticoagulant therapy | Condition Associated with Bleeding risk | Internal hemorrhage | Hemorrhage Clinical Significance | Bleeding tendency
Item
any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
boolean
C1301624 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C3251812 (UMLS CUI [2,3])
C1390214 (UMLS CUI [3])
C0019080 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C1458140 (UMLS CUI [5])
Comorbidity Severe | Atrial Fibrillation | Condition Requirement Chronic anticoagulation | Myocardial Infarction
Item
severe concomitant disease such as (a) atrial fibrillation (afib) or another condition that requires chronic anticoagulation (participants with isolated transient afib may be allowed at the discretion of the treating physician investigator) and (b) documented acute myocardial infarction (mi) during index event
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0694554 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
Cerebrovascular accident
Item
prior stroke within 90 days of randomization
boolean
C0038454 (UMLS CUI [1])
Hospitalization Duration
Item
has been hospitalized for longer than 21 days during the index event
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Inotropic agent Intravenous Planned
Item
planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
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