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Falhas:
ID
11733
Descrição
The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.
Palavras-chave
Versões (2)
- 28/07/2015 28/07/2015 -
- 21/11/2015 21/11/2015 -
Transferido a
28 de julho de 2015
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria: Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI (SWITCHIII)
Similar models
Eligibility Criteria
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender
Item
The patient is, male or female
boolean
C0079399 (UMLS CUI-1)
Age
Item
> 18 years of age
boolean
C0001779 (UMLS CUI-1)
Acute coronary syndrome
Item
The patient presents with coronary syndrome
boolean
C0948089 (UMLS CUI-1)
Acute coronary syndrome
Item
The patient presents with coronary syndrome
boolean
C0948089 (UMLS CUI-1)
Unstable angina
Item
unstable angina
boolean
C0002965 (UMLS CUI-1)
NSTEMI
Item
non ST segment elevated myocardial infarction (NSTEMI)
boolean
C3537184 (UMLS CUI-1)
Angiography
Item
The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease
boolean
C0085532 (UMLS CUI-1)
Informed consent
Item
The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
boolean
C0021430 (UMLS CUI-1)
STEMI
Item
ST elevated myocardial infarction within the preceding 48 hours
boolean
C1536220 (UMLS CUI-1)
Weight
Item
Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg)
boolean
C0005910 (UMLS CUI-1)
Bivalirudin
Item
Patients presenting on or received bivalirudin within the preceding 24 hours;
boolean
C0168273 (UMLS CUI-1)
GP IIb/IIIa Antagonist
Item
Patients presenting on or received GP IIb/IIIa inhibitors within the preceding 24 hours;
boolean
C3640054 (UMLS CUI-1)
LMWH
Item
Patients presenting on or received low-molecular weight heparin within the preceding 24 hours
boolean
C3536766 (UMLS CUI-1)
Unfractionated Heparin
Item
Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
boolean
C2825026 (UMLS CUI-1)
Bleeding risk
Item
Patients with known conditions of bleeding diathesis
boolean
C3251812 (UMLS CUI-1)
Hemorrhage
Item
Patients with actively bleeding within the previous 6 months (GI bleed etc.);
boolean
C0019080 (UMLS CUI-1)
Bacterial endocarditis
Item
Known diagnosis of acute bacterial endocarditis;
boolean
C0014121 (UMLS CUI-1)
Cardiogenic shock
Item
Patients with cardiogenic shock
boolean
C0036980 (UMLS CUI-1)
IABP
Item
Required intra-aortic balloon pump (IABP)
boolean
C0021860 (UMLS CUI-1)
Warfarin
Item
If patient is on warfarin (Coumadin) therapy
boolean
C0043031 (UMLS CUI-1)
History of stroke
Item
Patients who had a major or minor stroke (CVA or TIA)
boolean
C0559159 (UMLS CUI-1)
Major surgery
Item
Patients who had a major surgery within the past 6 months;
boolean
C0679637 (UMLS CUI-1)
Kidney failure
Item
Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L)
boolean
C0035078 (UMLS CUI-1)
Renal transplant
Item
status post renal transplant
boolean
C0022671 (UMLS CUI-1)
Hemodialysis
Item
patients on chronic dialysis
boolean
C0019004 (UMLS CUI-1)
Creatinine clearance
Item
creatinine clearance ≤ 30 ml/min
boolean
C0373595 (UMLS CUI-1)
Platelet count
Item
A platelet count of less than 100,000 cells/mm3;
boolean
C0032181 (UMLS CUI-1)
Medication allergy
Item
Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, that cannot be medically managed;
boolean
C0013182 (UMLS CUI-1)
Contrast media allergy
Item
Known allergies to contrast that cannot be medically managed;
boolean
C0570562 (UMLS CUI-1)
Prior angioplasty
Item
Prior angioplasty within the previous 30 days;
boolean
C3532648 (UMLS CUI-1)
LMWH contraindicated
Item
Contraindication to low-molecular weight heparin
boolean
C3536766 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
Unfractionated heparin contraindicated
Item
Contraindication to unfractionated heparin
boolean
C2825026 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
Bivalirudin contraindicated
Item
Contraindication to bivalirudin;
boolean
C0168273 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
C0522473 (UMLS CUI-2)
P (UMLS CUI-3)
Pregnancy
Item
Pregnant or lactating women;
boolean
C0549206 (UMLS CUI-1)
Lactating
Item
Pregnant or lactating women;
boolean
C2828358 (UMLS CUI-1)
Study patient
Item
Currently participating in an investigational drug or another device study.
boolean
C0422740 (UMLS CUI-1)