ID

18318

Descrição

A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN); ODM derived from: https://clinicaltrials.gov/show/NCT00060554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

Palavras-chave

Versões (1)
  1. 30/10/2016 30/10/2016 -
Transferido a

30 de outubro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Myocardial Infarction NCT00060554

Inglês

Eligibility Myocardial Infarction NCT00060554

1 Formulários  
Inclusion Criteria
Descrição

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).
Descrição

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

Tipo de dados

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
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
age < 21 years
Descrição

Age

Tipo de dados

boolean

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

Activated clotting time measurement

Tipo de dados

boolean

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

Heparin, Low-Molecular-Weight

Tipo de dados

boolean

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

oral anticoagulants | International Normalized Ratio

Tipo de dados

boolean

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

Thrombolytic Therapy ST segment elevation myocardial infarction

Tipo de dados

boolean

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

Internal hemorrhage | Bleeding tendency

Tipo de dados

boolean

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

Thrombocytopenia | Platelet Count measurement

Tipo de dados

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
Descrição

Pregnancy | Childbearing Potential Contraceptive methods Lacking

Tipo de dados

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
Descrição

Hypersensitivity Heparin | Hypersensitivity fondaparinux | Hypersensitivity Aspirin | Hypersensitivity clopidogrel

Tipo de dados

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
Descrição

Medical contraindication Absolute Anticoagulation Therapy

Tipo de dados

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.
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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