ID

31495

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)
  1. 8/28/18 8/28/18 -
  2. 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

English

Blinded Anticoagulation Form

1 forms  
Administrative Data
Description

Administrative Data

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

Patient ID; Centre Number

Data type

text

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

Patient ID; Envelope Number

Data type

text

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

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Study Drug Accountability
Description

Study Drug Accountability

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0078889
The treatment allocation for this patient was
Description

treatment allocation

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1706778
Was the patient given the treatment allocated?
Description

allocated treatment given

Data type

text

Alias
UMLS CUI [1,1]
C1706778
UMLS CUI [1,2]
C0580351
The actual treatment given to this patient was
Description

actual treatment

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0237400
ACT Measurement
Description

ACT Measurement

Alias
UMLS CUI-1
C0427611
Was an ACT measured during PCI procedure?
Description

ACT measurement during PCI

Data type

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1532338
Was the ACT revealed to the investigator or interventional cardiologist during PCI?
Description

ACT measurement; research personnel informed

Data type

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0035173
UMLS CUI [1,3]
C1522154
Was additional anticoagulant requested by the investigator during the PCI procedure?
Description

additional anticoagulant therapy during PCI

Data type

text

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C1532338
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Similar models

Blinded Anticoagulation Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Study Drug Accountability
C0013175 (UMLS CUI-1)
C0078889 (UMLS CUI-2)
Item
The treatment allocation for this patient was
text
C0087111 (UMLS CUI [1,1])
C1706778 (UMLS CUI [1,2])
treatment allocation
Code List
The treatment allocation for this patient was
CL Item
unfractionated heparin (unfractionated heparin)
CL Item
fondaparinux 2.5 mg (fondaparinux 2.5 mg)
CL Item
fondaparinux 5.0 mg (fondaparinux 5.0 mg)
Item
Was the patient given the treatment allocated?
text
C1706778 (UMLS CUI [1,1])
C0580351 (UMLS CUI [1,2])
allocated treatment given
Code List
Was the patient given the treatment allocated?
CL Item
Yes (Yes)
CL Item
No (give reason) (No (give reason))
Item
The actual treatment given to this patient was
text
C0087111 (UMLS CUI [1,1])
C0237400 (UMLS CUI [1,2])
actual treatment
Code List
The actual treatment given to this patient was
CL Item
unfractionated heparin (specify amount, brand name and lot number) (unfractionated heparin (specify amount, brand name and lot number))
CL Item
fondaparinux 2.5 mg (specify batch number) (fondaparinux 2.5 mg (specify batch number))
CL Item
fondaparinux 5.0 mg (specify batch number) (fondaparinux 5.0 mg (specify batch number))
Item Group
ACT Measurement
C0427611 (UMLS CUI-1)
Item
Was an ACT measured during PCI procedure?
text
C0427611 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
ACT measurement during PCI
Code List
Was an ACT measured during PCI procedure?
CL Item
No (No)
CL Item
Yes (give seconds, date and time) (Yes (give seconds, date and time))
Item
Was the ACT revealed to the investigator or interventional cardiologist during PCI?
text
C0427611 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1522154 (UMLS CUI [1,3])
ACT measurement; revelation investigator
Code List
Was the ACT revealed to the investigator or interventional cardiologist during PCI?
CL Item
No (No)
CL Item
Yes (give reason) (Yes (give reason))
Item
Was additional anticoagulant requested by the investigator during the PCI procedure?
text
C0150457 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,4])
undefined item
Code List
Was additional anticoagulant requested by the investigator during the PCI procedure?
CL Item
No (No)
CL Item
Yes - 2000 IU unfractioned heparin (give Brand name, Lot number, Date and time of injection) (Yes - 2000 IU unfractioned heparin (give Brand name, Lot number, Date and time of injection))
CL Item
Yes - fondaparinux 2.5mg (give Batch number, Date and time of injection) (Yes - fondaparinux 2.5mg (give Batch number, Date and time of injection))
CL Item
Yes - saline (give Date and time of injection) (Yes - saline (give Date and time of injection))
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