ID

18318

Description

A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN); ODM derived from: https://clinicaltrials.gov/show/NCT00060554

Link

https://clinicaltrials.gov/show/NCT00060554

Keywords

Versions (1)
  1. 10/30/16 10/30/16 -
Uploaded on

October 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Myocardial Infarction NCT00060554

English

Eligibility Myocardial Infarction NCT00060554

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
scheduled for pci, including pci for non-st elevation acute coronary syndromes (acs), primary pci for st elevation myocardial infarction (mi) or elective pci (with planned overnight stay in hospital). (patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" pci are also eligible).
Description

Percutaneous Coronary Intervention Planned | Non ST segment elevation acute coronary syndrome | Percutaneous Coronary Intervention Primary ST segment elevation myocardial infarction | Percutaneous Coronary Intervention elective | Cardiac Catheterization Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C3160886
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C0205225
UMLS CUI [3,3]
C1536220
UMLS CUI [4,1]
C1532338
UMLS CUI [4,2]
C0439608
UMLS CUI [5]
C0018795
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
activated clotting time (act) > 200 seconds immediately prior to pci
Description

Activated clotting time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0427611
use of low molecular weight heparin (lmwh) in the previous 6 hours before pci
Description

Heparin, Low-Molecular-Weight

Data type

boolean

Alias
UMLS CUI [1]
C0019139
currently receiving an oral anticoagulant (oac) agent with an inr > 1.8
Description

oral anticoagulants | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0354604
UMLS CUI [2]
C0525032
thrombolytic therapy for st elevation mi in the previous 24 hours before pci
Description

Thrombolytic Therapy ST segment elevation myocardial infarction

Data type

boolean

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

Internal hemorrhage | Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1]
C1390214
UMLS CUI [2]
C1458140
thrombocytopenia (platelet count < 100 x 10-9/l)
Description

Thrombocytopenia | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
pregnant women or women of childbearing potential who are not using an effective method of contraception
Description

Pregnancy | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel
Description

Hypersensitivity Heparin | Hypersensitivity fondaparinux | Hypersensitivity Aspirin | Hypersensitivity clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1098510
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0004057
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0070166
absolute contra-indication to anticoagulation
Description

Medical contraindication Absolute Anticoagulation Therapy

Data type

boolean

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

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Myocardial Infarction NCT00060554

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Percutaneous Coronary Intervention Planned | Non ST segment elevation acute coronary syndrome | Percutaneous Coronary Intervention Primary ST segment elevation myocardial infarction | Percutaneous Coronary Intervention elective | Cardiac Catheterization Procedures
Item
scheduled for pci, including pci for non-st elevation acute coronary syndromes (acs), primary pci for st elevation myocardial infarction (mi) or elective pci (with planned overnight stay in hospital). (patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" pci are also eligible).
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3160886 (UMLS CUI [2])
C1532338 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C1536220 (UMLS CUI [3,3])
C1532338 (UMLS CUI [4,1])
C0439608 (UMLS CUI [4,2])
C0018795 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Age
Item
age < 21 years
boolean
C0001779 (UMLS CUI [1])
Activated clotting time measurement
Item
activated clotting time (act) > 200 seconds immediately prior to pci
boolean
C0427611 (UMLS CUI [1])
Heparin, Low-Molecular-Weight
Item
use of low molecular weight heparin (lmwh) in the previous 6 hours before pci
boolean
C0019139 (UMLS CUI [1])
oral anticoagulants | International Normalized Ratio
Item
currently receiving an oral anticoagulant (oac) agent with an inr > 1.8
boolean
C0354604 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
Thrombolytic Therapy ST segment elevation myocardial infarction
Item
thrombolytic therapy for st elevation mi in the previous 24 hours before pci
boolean
C0040044 (UMLS CUI [1,1])
C1536220 (UMLS CUI [1,2])
Internal hemorrhage | Bleeding tendency
Item
active internal bleeding or history of hemorrhagic diathesis
boolean
C1390214 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet count < 100 x 10-9/l)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Pregnancy | Childbearing Potential Contraceptive methods Lacking
Item
pregnant women or women of childbearing potential who are not using an effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Hypersensitivity Heparin | Hypersensitivity fondaparinux | Hypersensitivity Aspirin | Hypersensitivity clopidogrel
Item
known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (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])
Medical contraindication Absolute Anticoagulation Therapy
Item
absolute contra-indication to anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0205344 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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