ID

31817

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-10-01 2018-10-01 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

1 oktober 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; NCT

Engelsk

Hospital Discharge Visit

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

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

Patient ID; Centre Number

Datatyp

text

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

Patient ID; Envelope Number

Datatyp

text

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

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
30 Day Follow-Up Visit
Beskrivning

30 Day Follow-Up Visit

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

follow-up; research method and research organization

Datatyp

text

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

Clinical events since randomization

Alias
UMLS CUI-1
C0877248
Death
Beskrivning

Adverse Event; Cessation of life

Datatyp

boolean

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

Adverse Event, Myocardial infarction; Adverse Event, Myocardial Reinfarction

Datatyp

boolean

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

Adverse Event, Revascularization

Datatyp

boolean

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

Adverse Event, Major bleed; Adverse event, Minor bleed

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Adverse Event, Cerebrovascular accident

Datatyp

boolean

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

Adverse Event, vascular access, Site of access, Hematoma

Datatyp

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
Beskrivning

Adverse Event, Pseudoaneurysm

Datatyp

boolean

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

Adverse Event, other

Datatyp

boolean

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

Interventions since Index PCI

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

Interventional Procedure; Coronary Angiography

Datatyp

boolean

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

Interventional Procedure; Percutaneous Coronary Intervention; Repeat Surgery

Datatyp

boolean

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

Interventional Procedure; Coronary Artery Bypass Surgery

Datatyp

boolean

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

Interventional Procedure; Thrombolytic Therapy

Datatyp

boolean

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

Interventional Procedure; Intra-Aortic Balloon Pumping

Datatyp

boolean

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

Interventional Procedure; Vascular Surgical Procedures

Datatyp

boolean

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

Concomitant Medication

Alias
UMLS CUI-1
C2347852
UFH
Beskrivning

Unfractionated Heparin [EPC]

Datatyp

text

Alias
UMLS CUI [1]
C2825026
LMWH
Beskrivning

Low Molecular Weight Heparin [EPC]

Datatyp

text

Alias
UMLS CUI [1]
C3536766
ASA
Beskrivning

Aspirin

Datatyp

text

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

Glycoprotein IIb/IIIa Antagonist

Datatyp

text

Alias
UMLS CUI [1]
C3640054
Bivalirudin or Hirudin
Beskrivning

Bivalirudin; Hirudin

Datatyp

text

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

Clopidogrel

Datatyp

text

Alias
UMLS CUI [1]
C0070166
Ticlopidine
Beskrivning

Ticlopidine

Datatyp

text

Alias
UMLS CUI [1]
C0040207
Oral anticoagulants
Beskrivning

Oral anticoagulants

Datatyp

text

Alias
UMLS CUI [1]
C0354604
COX II inhibitors
Beskrivning

COX II inhibitors

Datatyp

text

Alias
UMLS CUI [1]
C1257954
Other NSAIDs
Beskrivning

Anti-Inflammatory Agents, Non-Steroidal; Other

Datatyp

text

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

Nitrates

Datatyp

text

Alias
UMLS CUI [1]
C0028125
Beta-blockers
Beskrivning

Adrenergic beta-1 Receptor Antagonists

Datatyp

text

Alias
UMLS CUI [1]
C0304516
Calcium Channel Blockers
Beskrivning

Calcium Channel Blockers

Datatyp

text

Alias
UMLS CUI [1]
C0006684
ACE inhibitors
Beskrivning

Angiotensin-Converting Enzyme Inhibitors

Datatyp

text

Alias
UMLS CUI [1]
C0003015
ARB agents
Beskrivning

Angiotensin II receptor antagonist

Datatyp

text

Alias
UMLS CUI [1]
C0521942
Diuretics
Beskrivning

Diuretics

Datatyp

text

Alias
UMLS CUI [1]
C0012798
Statins
Beskrivning

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Datatyp

text

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

Antilipemic agent

Datatyp

text

Alias
UMLS CUI [1]
C0003367
Insulin
Beskrivning

Insulin

Datatyp

text

Alias
UMLS CUI [1]
C0021641
Oral hypoglycemic agents
Beskrivning

Oral hypoglycemic

Datatyp

text

Alias
UMLS CUI [1]
C0359086
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Similar models

Hospital Discharge Visit

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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])
undefined item
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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