ID

31328

Beschreibung

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

Stichworte

Versionen (1)
  1. 13/08/2018 13/08/2018 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13 de agosto de 2018

DOI

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Creative Commons BY-NC 3.0
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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574

Englisch

Randomization Form

1 Formulare  
  1. StudyEvent: ODM
    1. Randomization Form
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient ID, Centre No.
Beschreibung

Patient ID; Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2825181
UMLS CUI [1,3]
C1300638
Patient ID, Envelope No.
Beschreibung

Patient ID; Envelope Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2348585
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Eligibility Assessment
Beschreibung

Eligibility Assessment

Alias
UMLS CUI-1
C0013893
All eligibility criteria met
Beschreibung

eligibility criteria fulfilled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Interventional cardiologist meets minimum experience criteria
Beschreibung

Interventional cardiologist; experience

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175906
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0237607
Written informed consent obtained
Beschreibung

written informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1547186
Blood drawn for admission laboratory tests including cardiac enzymes/markers
Beschreibung

admission laboratory test; cardiac enzymes/markers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0443763
UMLS CUI [1,3]
C1271630
Additional blood drawn for central evaluation of inflammatory and coagulation markers
Beschreibung

inflammatory and coagulation markers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0005778
UMLS CUI [1,3]
C3805088
Baseline ECG within 24 hours prior to acute PCI or 1 week if elective PCI
Beschreibung

Baseline ECG, before

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0332152
Last Dose of Clopidogrel before PCI
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Dosage, Last

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0070166
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1517741
mg
Last Dose of Clopidogrel before PCI, Date
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Dosage, Last

Datentyp

date

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0070166
UMLS CUI [1,4]
C1762893
Last Dose of Clopidogrel before PCI, Time
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Time last dose

Datentyp

time

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0070166
UMLS CUI [1,4]
C0946444
Last Dose of ASA before PCI
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; ASA, dosage, last

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0004057
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1517741
mg
Last Dose of ASA before PCI, date
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; ASA, date last dose

Datentyp

date

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0004057
UMLS CUI [1,4]
C1762893
Last Dose of ASA before PCI, time
Beschreibung

Pretreatment, Percutaneous Coronary Intervention; ASA, Time last dose

Datentyp

time

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3539076
UMLS CUI [1,3]
C0004057
UMLS CUI [1,4]
C0946444
Weight in kilograms
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Treatment Allocation
Beschreibung

Treatment Allocation

Alias
UMLS CUI-1
C0034656
Investigator wishes to proceed with PCI
Beschreibung

undefined item

Datentyp

text

Has patient received a GPIIb/IIIa inhibitor or is there a plan for upfront use?
Beschreibung

GPIIb/IIIa inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C3640054
Date patient randomized
Beschreibung

Randomization Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Time patient randomized
Beschreibung

Randomization Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0040223
Date study drug injected
Beschreibung

Study drug injection; date

Datentyp

date

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0011008
Time study drug injected
Beschreibung

Study drug injection; time

Datentyp

time

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Randomization Form

1 Formulare
  1. StudyEvent: ODM
    1. Randomization Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Eligibility Assessment
C0013893 (UMLS CUI-1)
eligibility criteria fulfilled
Item
All eligibility criteria met
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Interventional cardiologist; experience
Item
Interventional cardiologist meets minimum experience criteria
boolean
C0175906 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0237607 (UMLS CUI [1,3])
written informed consent
Item
Written informed consent obtained
boolean
C0021430 (UMLS CUI [1,1])
C1547186 (UMLS CUI [1,2])
admission laboratory test; cardiac enzymes/markers
Item
Blood drawn for admission laboratory tests including cardiac enzymes/markers
boolean
C0022885 (UMLS CUI [1,1])
C0443763 (UMLS CUI [1,2])
C1271630 (UMLS CUI [1,3])
inflammatory and coagulation markers
Item
Additional blood drawn for central evaluation of inflammatory and coagulation markers
boolean
C0022885 (UMLS CUI [1,1])
C0005778 (UMLS CUI [1,2])
C3805088 (UMLS CUI [1,3])
Baseline ECG, before
Item
Baseline ECG within 24 hours prior to acute PCI or 1 week if elective PCI
boolean
C1623258 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Dosage, Last
Item
Last Dose of Clopidogrel before PCI
float
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0070166 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Dosage, Last
Item
Last Dose of Clopidogrel before PCI, Date
date
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0070166 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,4])
Pretreatment, Percutaneous Coronary Intervention; clopidogrel, Time last dose
Item
Last Dose of Clopidogrel before PCI, Time
time
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0070166 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
Pretreatment, Percutaneous Coronary Intervention; ASA, dosage, last
Item
Last Dose of ASA before PCI
float
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Pretreatment, Percutaneous Coronary Intervention; ASA, date last dose
Item
Last Dose of ASA before PCI, date
date
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,4])
Pretreatment, Percutaneous Coronary Intervention; ASA, Time last dose
Item
Last Dose of ASA before PCI, time
time
C1532338 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0004057 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
Body Weight
Item
Weight in kilograms
float
C0005910 (UMLS CUI [1])
Item Group
Treatment Allocation
C0034656 (UMLS CUI-1)
undefined item
Item
Investigator wishes to proceed with PCI
text
GPIIb/IIIa inhibitor
Item
Has patient received a GPIIb/IIIa inhibitor or is there a plan for upfront use?
boolean
C3640054 (UMLS CUI [1])
Randomization Date
Item
Date patient randomized
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization Time
Item
Time patient randomized
time
C0034656 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Study drug injection; date
Item
Date study drug injected
date
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Study drug injection; time
Item
Time study drug injected
time
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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