ID
31496
Description
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism
Keywords
Versions (2)
- 8/28/18 8/28/18 -
- 8/28/18 8/28/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 28, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Study ID: 104574
Baseline Form
- StudyEvent: ODM
Description
Patient Information
Alias
- UMLS CUI-1
- C1955348
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Ethnic Group
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Clinical Assessment Pre-Randomization
Alias
- UMLS CUI-1
- C4534461
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0034656
Description
Symptoms/procedure inducing PCI; date of onset
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205263
- UMLS CUI [1,3]
- C1532338
- UMLS CUI [1,4]
- C0574845
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C0205263
- UMLS CUI [2,3]
- C1532338
- UMLS CUI [2,4]
- C0574845
Description
Symptoms/procedure inducing PCI; time of onset
Data type
time
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205263
- UMLS CUI [1,3]
- C1532338
- UMLS CUI [1,4]
- C0449244
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C0205263
- UMLS CUI [2,3]
- C1532338
- UMLS CUI [2,4]
- C0449244
Description
Baseline ECG; date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0011008
Description
Baseline ECG; time
Data type
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0040223
Description
Baseline ECG; result
Data type
text
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C1274040
Description
ECG rhythm
Data type
text
Alias
- UMLS CUI [1]
- C0232187
Description
Left ventricular hypertrophy
Data type
text
Alias
- UMLS CUI [1]
- C0149721
Description
Intraventricular conduction delay (QRS > 120 msec)
Data type
text
Alias
- UMLS CUI [1,1]
- C3697597
- UMLS CUI [1,2]
- C0429025
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Supine blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
Description
Pre-Randomization Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0034656
Description
Laboratory Procedures; Specimen collection date
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1302413
Description
Laboratory Procedures; Specimen collection time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
Description
Hemoglobin
Data type
float
Measurement units
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Description
Hematocrit level
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0518014
Description
Total WBC
Data type
float
Measurement units
- x 10⁹/L
Alias
- UMLS CUI [1]
- C0023508
Description
Platelet Count
Data type
integer
Measurement units
- x 10⁹/L
Alias
- UMLS CUI [1]
- C0005821
Description
aPTT
Data type
integer
Measurement units
- sec
Alias
- UMLS CUI [1]
- C0030605
Description
INR
Data type
float
Alias
- UMLS CUI [1]
- C0525032
Description
Creatinine
Data type
float
Measurement units
- µmol/L
Alias
- UMLS CUI [1]
- C0201976
Description
Total CK
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201973
Description
Total CK; ULN
Data type
integer
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C1519815
Description
CK-MB
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0523584
Description
CK-MB; ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1519815
Description
CK-MB
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0523584
Description
CK-MB; ULN
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1519815
Description
CK-MB Mass
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1306372
Description
CK-MB Mass ULN
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1306372
- UMLS CUI [1,3]
- C1519815
Description
Troponin T
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1]
- C1141947
Description
Troponin T; ULN
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1,1]
- C1141947
- UMLS CUI [1,2]
- C1519815
Description
Troponin I
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1]
- C0920210
Description
Troponin I; ULN
Data type
float
Measurement units
- µg/L
Alias
- UMLS CUI [1,1]
- C0920210
- UMLS CUI [1,2]
- C1519815
Description
Patient History
Alias
- UMLS CUI-1
- C0679831
Description
Patient History; MI
Data type
boolean
Alias
- UMLS CUI [1]
- C1275835
Description
Patient History; MI; Date of most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C1275835
- UMLS CUI [1,2]
- C2924287
- UMLS CUI [1,3]
- C1513491
Description
Patient History; Previous PCI with stent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0038257
Description
Patient History; Previous PCI with stent; Date of most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0038257
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [1,5]
- C1513491
Description
Patient History; Previous PCI without stent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
Description
Patient History; Previous PCI without stent; Date of most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Description
Patient History; CABG Surgery
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
Description
Patient History; CABG Surgery, Date of most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Description
Patient History; CABG Surgery, Date of most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Description
Patient History; Coronary Artery Disease, Evidence, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1956346
- UMLS CUI [1,3]
- C0332120
- UMLS CUI [1,4]
- C0205394
Description
Patient History; Family history; Coronary Artery Disease, Early-onset
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0241889
- UMLS CUI [1,3]
- C1956346
- UMLS CUI [1,4]
- C1833334
Description
Patient History; Stroke
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0038454
Description
Patient History; Stroke; Date in time; most recent
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0038454
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Description
Patient History; Peripheral arterial disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1704436
Description
Patient History; Hypertension
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0020538
Description
Patient History; Heart Failure
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0018801
Description
Patient History; Diabetes
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0011849
Description
Patient History; Diabetes; Date of diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0011849
- UMLS CUI [1,3]
- C2316983
Description
Patient History; Hypercholesterolemia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0020443
Description
Patient History; Malignant Neoplasms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
Description
Patient History; Malignant Neoplasms, date of diagnosis
Data type
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [1,3]
- C2316983
Description
Patient History; Malignant Neoplasms, site
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [1,3]
- C1515974
Description
Patient History; concomitant disease
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0243087
Description
Patient History; smoker
Data type
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0243087
Similar models
Baseline Form
- StudyEvent: ODM
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
C2348585 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0574845 (UMLS CUI [2,4])
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0449244 (UMLS CUI [2,4])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
C1302413 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1306372 (UMLS CUI [1,2])
C1306372 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C2924287 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1513491 (UMLS CUI [1,5])
C1532338 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C0010055 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C1956346 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0241889 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
C1833334 (UMLS CUI [1,4])
C0038454 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C1704436 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C0020443 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0243087 (UMLS CUI [1,2])
C0243087 (UMLS CUI [1,2])