ID

31817

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

  1. 10/1/18 10/1/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 1, 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

Hospital Discharge Visit

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
30 Day Follow-Up Visit
Description

30 Day Follow-Up Visit

Alias
UMLS CUI-1
C0589121
How were these follow-up data obtained?
Description

follow-up; research method and research organization

Data type

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0681794
Clinical events since randomization
Description

Clinical events since randomization

Alias
UMLS CUI-1
C0877248
Death
Description

Adverse Event; Cessation of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011065
Myocardial (re)Infarction
Description

Adverse Event, Myocardial infarction; Adverse Event, Myocardial Reinfarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0027051
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0948369
Revascularization
Description

Adverse Event, Revascularization

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0581603
Clinically overt major and/or minor bleed
Description

Adverse Event, Major bleed; Adverse event, Minor bleed

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3160769
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C3160770
Non-fatal cardiac arrest/life threatening arrhythmia
Description

Adverse Event, Cardiac Arrest; Adverse Event, Cardiac Arrhythmia, Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0018790
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0003811
UMLS CUI [2,3]
C2826244
Stroke
Description

Adverse Event, Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0038454
Vascular Access Site Hematoma
Description

Adverse Event, vascular access, Site of access, Hematoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750138
UMLS CUI [1,3]
C0589360
UMLS CUI [1,4]
C0018944
Pseudoaneurysm requiring closure
Description

Adverse Event, Pseudoaneurysm

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510412
Has patient experienced any other untoward medical occurrence?
Description

Adverse Event, other

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205394
Interventions since Index PCI
Description

Interventions since Index PCI

Alias
UMLS CUI-1
C0184661
UMLS CUI-2
C1711239
UMLS CUI-3
C1532338
Coronary angiography
Description

Interventional Procedure; Coronary Angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0085532
Repeat PCI
Description

Interventional Procedure; Percutaneous Coronary Intervention; Repeat Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0035110
CABG
Description

Interventional Procedure; Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0010055
Thrombolytic Therapy
Description

Interventional Procedure; Thrombolytic Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0040044
Intra-aortic balloon pump
Description

Interventional Procedure; Intra-Aortic Balloon Pumping

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0021860
Other vascular procedure(s):
Description

Interventional Procedure; Vascular Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0042381
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
UFH
Description

Unfractionated Heparin [EPC]

Data type

text

Alias
UMLS CUI [1]
C2825026
LMWH
Description

Low Molecular Weight Heparin [EPC]

Data type

text

Alias
UMLS CUI [1]
C3536766
ASA
Description

Aspirin

Data type

text

Alias
UMLS CUI [1]
C0004057
GPIIb/IIIa inhibitor
Description

Glycoprotein IIb/IIIa Antagonist

Data type

text

Alias
UMLS CUI [1]
C3640054
Bivalirudin or Hirudin
Description

Bivalirudin; Hirudin

Data type

text

Alias
UMLS CUI [1]
C0168273
UMLS CUI [2]
C0019573
Clopidogrel
Description

Clopidogrel

Data type

text

Alias
UMLS CUI [1]
C0070166
Ticlopidine
Description

Ticlopidine

Data type

text

Alias
UMLS CUI [1]
C0040207
Oral anticoagulants
Description

Oral anticoagulants

Data type

text

Alias
UMLS CUI [1]
C0354604
COX II inhibitors
Description

COX II inhibitors

Data type

text

Alias
UMLS CUI [1]
C1257954
Other NSAIDs
Description

Anti-Inflammatory Agents, Non-Steroidal; Other

Data type

text

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205394
Nitrates
Description

Nitrates

Data type

text

Alias
UMLS CUI [1]
C0028125
Beta-blockers
Description

Adrenergic beta-1 Receptor Antagonists

Data type

text

Alias
UMLS CUI [1]
C0304516
Calcium Channel Blockers
Description

Calcium Channel Blockers

Data type

text

Alias
UMLS CUI [1]
C0006684
ACE inhibitors
Description

Angiotensin-Converting Enzyme Inhibitors

Data type

text

Alias
UMLS CUI [1]
C0003015
ARB agents
Description

Angiotensin II receptor antagonist

Data type

text

Alias
UMLS CUI [1]
C0521942
Diuretics
Description

Diuretics

Data type

text

Alias
UMLS CUI [1]
C0012798
Statins
Description

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Data type

text

Alias
UMLS CUI [1]
C0360714
Other lipid lowering agents
Description

Antilipemic agent

Data type

text

Alias
UMLS CUI [1]
C0003367
Insulin
Description

Insulin

Data type

text

Alias
UMLS CUI [1]
C0021641
Oral hypoglycemic agents
Description

Oral hypoglycemic

Data type

text

Alias
UMLS CUI [1]
C0359086

Similar models

Hospital Discharge Visit

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
30 Day Follow-Up Visit
C0589121 (UMLS CUI-1)
Item
How were these follow-up data obtained?
text
C1522577 (UMLS CUI [1,1])
C0681794 (UMLS CUI [1,2])
Code List
How were these follow-up data obtained?
CL Item
office visit (office visit)
CL Item
home visit (home visit)
CL Item
telephone communication (telephone communication)
CL Item
Patient in hospital, not discharged after initial PCI (Patient in hospital, not discharged after initial PCI)
CL Item
Patient in hospital, readmitted to hospital after initial PCI (Patient in hospital, readmitted to hospital after initial PCI)
CL Item
written communication (written communication)
CL Item
other (specify) (other (specify))
Item Group
Clinical events since randomization
C0877248 (UMLS CUI-1)
Adverse Event; Cessation of life
Item
Death
boolean
C0877248 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Adverse Event, Myocardial infarction; Adverse Event, Myocardial Reinfarction
Item
Myocardial (re)Infarction
boolean
C0877248 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0948369 (UMLS CUI [2,2])
Adverse Event, Revascularization
Item
Revascularization
boolean
C0877248 (UMLS CUI [1,1])
C0581603 (UMLS CUI [1,2])
Adverse Event, Major bleed; Adverse event, Minor bleed
Item
Clinically overt major and/or minor bleed
boolean
C0877248 (UMLS CUI [1,1])
C3160769 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C3160770 (UMLS CUI [2,2])
Adverse Event, Cardiac Arrest; Adverse Event, Cardiac Arrhythmia, Life Threatening
Item
Non-fatal cardiac arrest/life threatening arrhythmia
boolean
C0877248 (UMLS CUI [1,1])
C0018790 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
Adverse Event, Cerebrovascular accident
Item
Stroke
boolean
C0877248 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Adverse Event, vascular access, Site of access, Hematoma
Item
Vascular Access Site Hematoma
boolean
C0877248 (UMLS CUI [1,1])
C0750138 (UMLS CUI [1,2])
C0589360 (UMLS CUI [1,3])
C0018944 (UMLS CUI [1,4])
Adverse Event, Pseudoaneurysm
Item
Pseudoaneurysm requiring closure
boolean
C0877248 (UMLS CUI [1,1])
C1510412 (UMLS CUI [1,2])
Adverse Event, other
Item
Has patient experienced any other untoward medical occurrence?
boolean
C0877248 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Interventions since Index PCI
C0184661 (UMLS CUI-1)
C1711239 (UMLS CUI-2)
C1532338 (UMLS CUI-3)
Interventional Procedure; Coronary Angiography
Item
Coronary angiography
boolean
C0184661 (UMLS CUI [1,1])
C0085532 (UMLS CUI [1,2])
Interventional Procedure; Percutaneous Coronary Intervention; Repeat Surgery
Item
Repeat PCI
boolean
C0184661 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Interventional Procedure; Coronary Artery Bypass Surgery
Item
CABG
boolean
C0184661 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Interventional Procedure; Thrombolytic Therapy
Item
Thrombolytic Therapy
boolean
C0184661 (UMLS CUI [1,1])
C0040044 (UMLS CUI [1,2])
Interventional Procedure; Intra-Aortic Balloon Pumping
Item
Intra-aortic balloon pump
boolean
C0184661 (UMLS CUI [1,1])
C0021860 (UMLS CUI [1,2])
Interventional Procedure; Vascular Surgical Procedures
Item
Other vascular procedure(s):
boolean
C0184661 (UMLS CUI [1,1])
C0042381 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
UFH
text
C2825026 (UMLS CUI [1])
Code List
UFH
CL Item
Give start and end date and time (Give start and end date and time)
Item
LMWH
text
C3536766 (UMLS CUI [1])
Code List
LMWH
CL Item
Give start and end date and time (Give start and end date and time)
Item
ASA
text
C0004057 (UMLS CUI [1])
Code List
ASA
CL Item
Give start and end date and time (Give start and end date and time)
Item
GPIIb/IIIa inhibitor
text
C3640054 (UMLS CUI [1])
Code List
GPIIb/IIIa inhibitor
CL Item
Give start and end date and time (Give start and end date and time)
Item
Bivalirudin or Hirudin
text
C0168273 (UMLS CUI [1])
C0019573 (UMLS CUI [2])
Code List
Bivalirudin or Hirudin
CL Item
Give start and end date and time (Give start and end date and time)
Item
Clopidogrel
text
C0070166 (UMLS CUI [1])
Code List
Clopidogrel
CL Item
Give start and end date and time (Give start and end date and time)
Item
Ticlopidine
text
C0040207 (UMLS CUI [1])
Code List
Ticlopidine
CL Item
Give start and end date and time (Give start and end date and time)
Item
Oral anticoagulants
text
C0354604 (UMLS CUI [1])
Code List
Oral anticoagulants
CL Item
Give start and end date and time (Give start and end date and time)
Item
COX II inhibitors
text
C1257954 (UMLS CUI [1])
Code List
COX II inhibitors
CL Item
Give start and end date and time (Give start and end date and time)
Item
Other NSAIDs
text
C0003211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other NSAIDs
CL Item
Give start and end date and time (Give start and end date and time)
Item
Nitrates
text
C0028125 (UMLS CUI [1])
Code List
Nitrates
CL Item
Give start and end date and time (Give start and end date and time)
Item
Beta-blockers
text
C0304516 (UMLS CUI [1])
Code List
Beta-blockers
CL Item
Give start and end date and time (Give start and end date and time)
Item
Calcium Channel Blockers
text
C0006684 (UMLS CUI [1])
Code List
Calcium Channel Blockers
CL Item
Give start and end date and time (Give start and end date and time)
Item
ACE inhibitors
text
C0003015 (UMLS CUI [1])
Code List
ACE inhibitors
CL Item
Give start and end date and time (Give start and end date and time)
Item
ARB agents
text
C0521942 (UMLS CUI [1])
Code List
ARB agents
CL Item
Give start and end date and time (Give start and end date and time)
Item
Diuretics
text
C0012798 (UMLS CUI [1])
Code List
Diuretics
CL Item
Give start and end date and time (Give start and end date and time)
Item
Statins
text
C0360714 (UMLS CUI [1])
Code List
Statins
CL Item
Give start and end date and time (Give start and end date and time)
Item
Other lipid lowering agents
text
C0003367 (UMLS CUI [1])
Code List
Other lipid lowering agents
CL Item
Give start and end date and time (Give start and end date and time)
Item
Insulin
text
C0021641 (UMLS CUI [1])
Code List
Insulin
CL Item
Give start and end date and time (Give start and end date and time)
Item
Oral hypoglycemic agents
text
C0359086 (UMLS CUI [1])
Code List
Oral hypoglycemic agents
CL Item
Give start and end date and time (Give start and end date and time)

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