ID

31315

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

GlaxoSmithKline

Uploaded on

August 13, 2018

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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; Clinical Study ID: AR1104574

English

Patient Eligibility 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
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patient scheduled for percutaneous coronary intervention (specify reason)
Description

Percutaneous Coronary Intervention, scheduled

Data type

text

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0205539
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1547186
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Age > 21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ACT > 200 seconds immediately prior to PCI (record ACT)
Description

ACT

Data type

boolean

Alias
UMLS CUI [1]
C0427611
Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
Description

low molecular weight heparin; previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0019139
UMLS CUI [1,2]
C0205156
Currently receiving an oral anticoagulant agent (OAC) with an INR > 1.8
Description

oral anticoagulant agent

Data type

boolean

Alias
UMLS CUI [1]
C0354604
Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
Description

thrombolytic therapy for ST elevation MI

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0040044
Active internal bleeding or history of hemorrhagic diathesis
Description

active internal bleeding; hemorrhagic diathesis

Data type

boolean

Alias
UMLS CUI [1]
C1390214
UMLS CUI [2]
C1458140
Thrombocytopenia (platelet count < 100 x 109/L)
Description

Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0040034
Pregnant women or women of childbearing potential who are not using an effective method of contraception
Description

Pregnancy; No effective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1298908
Known allergy to UFH, fondaparinux, ASA or clopidogrel
Description

Unfractionated Heparin Hypersensitivity; fondaparinux Hypersensitivity; Aspirin Hypersensitivity; clopidogrel Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C2825026
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C1098510
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0004057
UMLS CUI [3,2]
C0020517
UMLS CUI [4,1]
C0070166
UMLS CUI [4,2]
C0020517
Absolute contra-indication to anticoagulation
Description

anticoagulation contra-indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0205344
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrolment or prior participation in this study.
Description

Study Subject Participation Status; Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
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Similar models

Patient Eligibility 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
Inclusion Criteria
C1512693 (UMLS CUI-1)
Item
Patient scheduled for percutaneous coronary intervention (specify reason)
text
C1532338 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Percutaneous Coronary Intervention, scheduled
Code List
Patient scheduled for percutaneous coronary intervention (specify reason)
CL Item
No (No)
CL Item
Non ST elevation ACS (Non ST elevation ACS)
CL Item
Primary PCI (STEMI) (Primary PCI (STEMI))
CL Item
Elective PCI (with planned overnight stay) (Elective PCI (with planned overnight stay))
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1547186 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Age
Item
Age > 21 years
boolean
C0001779 (UMLS CUI [1])
ACT
Item
ACT > 200 seconds immediately prior to PCI (record ACT)
boolean
C0427611 (UMLS CUI [1])
low molecular weight heparin; previous
Item
Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
boolean
C0019139 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
oral anticoagulant agent
Item
Currently receiving an oral anticoagulant agent (OAC) with an INR > 1.8
boolean
C0354604 (UMLS CUI [1])
thrombolytic therapy for ST elevation MI
Item
Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
boolean
C1536220 (UMLS CUI [1,1])
C0040044 (UMLS CUI [1,2])
active internal bleeding; hemorrhagic diathesis
Item
Active internal bleeding or history of hemorrhagic diathesis
boolean
C1390214 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
Thrombocytopenia
Item
Thrombocytopenia (platelet count < 100 x 109/L)
boolean
C0040034 (UMLS CUI [1])
Pregnancy; No effective contraception
Item
Pregnant women or women of childbearing potential who are not using an effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
Unfractionated Heparin Hypersensitivity; fondaparinux Hypersensitivity; Aspirin Hypersensitivity; clopidogrel Hypersensitivity
Item
Known allergy to UFH, fondaparinux, ASA or clopidogrel
boolean
C2825026 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1098510 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0004057 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0070166 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
anticoagulation contra-indication
Item
Absolute contra-indication to anticoagulation
boolean
C0003281 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0205344 (UMLS CUI [1,3])
Study Subject Participation Status; Investigational New Drugs
Item
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrolment or prior participation in this study.
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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