ID

31317

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 USE THIS PAGE ONLY FOR THOSE PATIENTS WHO DID NOT COMPLETE 30 DAY FOLLOW-UP VISIT (as per protocol, that is, 30-35 days from randomization)

Keywords

Versions (2)
  1. 8/13/18 8/13/18 -
  2. 8/13/18 8/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 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; NCT

English

Contact Form

1 forms  
  1. StudyEvent: ODM
    1. Contact Form
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
Contact
Description

Contact

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0681850
Has successful contact been made?
Description

Successful contact made

Data type

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0597535
Date of this contact
Description

Successful contact made; date

Data type

date

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0011008
Date this form completed
Description

date form completed

Data type

date

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1115437
Who made this contact?
Description

Contact made by

Data type

text

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1272683
How were follow-up data obtained?
Description

Follow-up; method

Data type

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0025663
Who was contacted?
Description

contact person

Data type

text

Alias
UMLS CUI [1]
C0337611
Did patient experience death since last seen and before 35 days after randomization?
Description

Death

Data type

text

Alias
UMLS CUI [1]
C0011065
Did patient experience myocardial (re)infarction since last seen and before 35 days after randomization?
Description

myocardal infarction; myocardial reinfarction

Data type

text

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948369
Did patient experience a stroke since last seen and before 35 days after randomization?
Description

Cerebrovascular event

Data type

text

Alias
UMLS CUI [1]
C0038454
Did patient experience a PCI/stent since last seen and before 35 days after randomization?
Description

PCI; stent

Data type

text

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0038257
Did patient experience CABG since last seen and before 35 days after randomization?
Description

CABG

Data type

text

Alias
UMLS CUI [1]
C0010055
Did patient experience bleeding since last seen and before 35 days after randomization?
Description

Bleeding

Data type

text

Alias
UMLS CUI [1]
C0019080
Additional Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Contact Form

1 forms
  1. StudyEvent: ODM
    1. Contact Form
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
Contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
Successful contact made
Item
Has successful contact been made?
boolean
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0597535 (UMLS CUI [1,3])
Successful contact made; date
Item
Date of this contact
date
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
date form completed
Item
Date this form completed
date
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1115437 (UMLS CUI [1,3])
Item
Who made this contact?
text
C0337611 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
Contact made by
Code List
Who made this contact?
CL Item
Investigator/Co-Investigator (Investigator/Co-Investigator)
CL Item
Study Nurse (Study Nurse)
CL Item
Other qualified professional (specify) (Other qualified professional (specify))
Item
How were follow-up data obtained?
text
C1522577 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
Follow-up; method
Code List
How were follow-up data obtained?
CL Item
late office visit (late office visit)
CL Item
home visit (home visit)
CL Item
written communication (written communication)
CL Item
patient in hospital (patient in hospital)
CL Item
telephone communication (telephone communication)
CL Item
other (specify) (other (specify))
Item
Who was contacted?
text
C0337611 (UMLS CUI [1])
contact person
Code List
Who was contacted?
CL Item
patient (patient)
CL Item
patient’s relative (relationship) (patient’s relative (relationship))
CL Item
patient’s physician (patient’s physician)
CL Item
other (please specify) (other (please specify))
Item
Did patient experience death since last seen and before 35 days after randomization?
text
C0011065 (UMLS CUI [1])
Death
Code List
Did patient experience death since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Item
Did patient experience myocardial (re)infarction since last seen and before 35 days after randomization?
text
C0027051 (UMLS CUI [1])
C0948369 (UMLS CUI [2])
myocardal infarction; myocardial reinfarction
Code List
Did patient experience myocardial (re)infarction since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Item
Did patient experience a stroke since last seen and before 35 days after randomization?
text
C0038454 (UMLS CUI [1])
myocardal infarction; myocardial reinfarction
Code List
Did patient experience a stroke since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Item
Did patient experience a PCI/stent since last seen and before 35 days after randomization?
text
C1532338 (UMLS CUI [1,1])
C0038257 (UMLS CUI [1,2])
myocardal infarction; myocardial reinfarction
Code List
Did patient experience a PCI/stent since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Item
Did patient experience CABG since last seen and before 35 days after randomization?
text
C0010055 (UMLS CUI [1])
myocardal infarction; myocardial reinfarction
Code List
Did patient experience CABG since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Item
Did patient experience bleeding since last seen and before 35 days after randomization?
text
C0019080 (UMLS CUI [1])
myocardal infarction; myocardial reinfarction
Code List
Did patient experience bleeding since last seen and before 35 days after randomization?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (give date) (Yes (give date))
Comments
Item
Additional Comments
text
C0947611 (UMLS CUI [1])
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