ID

12472

Beschreibung

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. https://clinicaltrials.gov/ct2/show/NCT00464087

Link

https://clinicaltrials.gov/ct2/show/NCT00464087

Stichworte

Versionen (2)
  1. 28.07.15 28.07.15 -
  2. 21.11.15 21.11.15 -
Hochgeladen am

21. November 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility SWITCHIII Acute Coronary Syndrome NCT00464087

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

The patient is, male or female
Beschreibung

The patient is, male or female

Datentyp

boolean

Alias
UMLS CUI-1
C0079399
> 18 years of age
Beschreibung

> 18 years of age

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
The patient presents with coronary syndrome
Beschreibung

The patient presents with coronary syndrome

Datentyp

boolean

Alias
UMLS CUI-1
C0948089
The patient presents with coronary syndrome
Beschreibung

The patient presents with coronary syndrome

Datentyp

boolean

Alias
UMLS CUI-1
C0948089
unstable angina
Beschreibung

unstable angina

Datentyp

boolean

Alias
UMLS CUI-1
C0002965
non ST segment elevated myocardial infarction (NSTEMI)
Beschreibung

non ST segment elevated myocardial infarction (NSTEMI)

Datentyp

boolean

Alias
UMLS CUI-1
C3537184
The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease
Beschreibung

The patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease

Datentyp

boolean

Alias
UMLS CUI-1
C0085532
The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
Beschreibung

The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.

Datentyp

boolean

Alias
UMLS CUI-1
C0021430
Exclusion criteria
Beschreibung

Exclusion criteria

ST elevated myocardial infarction within the preceding 48 hours
Beschreibung

ST elevated myocardial infarction within the preceding 48 hours

Datentyp

boolean

Alias
UMLS CUI-1
C1536220
Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg)
Beschreibung

Patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg)

Datentyp

boolean

Alias
UMLS CUI-1
C0005910
Patients presenting on or received bivalirudin within the preceding 24 hours;
Beschreibung

Patients presenting on or received bivalirudin within the preceding 24 hours;

Datentyp

boolean

Alias
UMLS CUI-1
C0168273
Patients presenting on or received GP IIb/IIIa inhibitors within the preceding 24 hours;
Beschreibung

Patients presenting on or received GP IIb/IIIa inhibitors within the preceding 24 hours;

Datentyp

boolean

Alias
UMLS CUI-1
C3640054
Patients presenting on or received low-molecular weight heparin within the preceding 24 hours
Beschreibung

Patients presenting on or received low-molecular weight heparin within the preceding 24 hours

Datentyp

boolean

Alias
UMLS CUI-1
C3536766
Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.
Beschreibung

Patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration.

Datentyp

boolean

Alias
UMLS CUI-1
C2825026
Patients with known conditions of bleeding diathesis
Beschreibung

Patients with known conditions of bleeding diathesis

Datentyp

boolean

Alias
UMLS CUI-1
C3251812
Patients with actively bleeding within the previous 6 months (GI bleed etc.);
Beschreibung

Patients with actively bleeding within the previous 6 months (GI bleed etc.);

Datentyp

boolean

Alias
UMLS CUI-1
C0019080
Known diagnosis of acute bacterial endocarditis;
Beschreibung

Known diagnosis of acute bacterial endocarditis;

Datentyp

boolean

Alias
UMLS CUI-1
C0014121
Patients with cardiogenic shock
Beschreibung

Patients with cardiogenic shock

Datentyp

boolean

Alias
UMLS CUI-1
C0036980
Required intra-aortic balloon pump (IABP)
Beschreibung

Required intra-aortic balloon pump (IABP)

Datentyp

boolean

Alias
UMLS CUI-1
C0021860
If patient is on warfarin (Coumadin) therapy
Beschreibung

If patient is on warfarin (Coumadin) therapy

Datentyp

boolean

Alias
UMLS CUI-1
C0043031
Patients who had a major or minor stroke (CVA or TIA)
Beschreibung

Patients who had a major or minor stroke (CVA or TIA)

Datentyp

boolean

Alias
UMLS CUI-1
C0559159
Patients who had a major surgery within the past 6 months;
Beschreibung

Patients who had a major surgery within the past 6 months;

Datentyp

boolean

Alias
UMLS CUI-1
C0679637
Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L)
Beschreibung

Known impaired renal function (creatinine ≥ 3.0 mg/dL (265.2 μmol/L)

Datentyp

boolean

Alias
UMLS CUI-1
C0035078
status post renal transplant
Beschreibung

status post renal transplant

Datentyp

boolean

Alias
UMLS CUI-1
C0022671
patients on chronic dialysis
Beschreibung

patients on chronic dialysis

Datentyp

boolean

Alias
UMLS CUI-1
C0019004
creatinine clearance ≤ 30 ml/min
Beschreibung

creatinine clearance ≤ 30 ml/min

Datentyp

boolean

Alias
UMLS CUI-1
C0373595
A platelet count of less than 100,000 cells/mm3;
Beschreibung

A platelet count of less than 100,000 cells/mm3;

Datentyp

boolean

Alias
UMLS CUI-1
C0032181
Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, that cannot be medically managed;
Beschreibung

Known allergies to fondaparinux, aspirin, clopidogrel bisulfate (PlavixR), ticlopidine (TiclidR), heparin, bivalirudin, that cannot be medically managed;

Datentyp

boolean

Alias
UMLS CUI-1
C0013182
Known allergies to contrast that cannot be medically managed;
Beschreibung

Known allergies to contrast that cannot be medically managed;

Datentyp

boolean

Alias
UMLS CUI-1
C0570562
Prior angioplasty within the previous 30 days;
Beschreibung

Prior angioplasty within the previous 30 days;

Datentyp

boolean

Alias
UMLS CUI-1
C3532648
Contraindication to low-molecular weight heparin
Beschreibung

Contraindication to low-molecular weight heparin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3536766
UMLS CUI [1,2]
C0522473
Contraindication to unfractionated heparin
Beschreibung

Contraindication to unfractionated heparin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825026
UMLS CUI [1,2]
C0522473
Contraindication to bivalirudin;
Beschreibung

Contraindication to bivalirudin;

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0168273
UMLS CUI [1,2]
C0522473
Pregnant or lactating women;
Beschreibung

Pregnant or lactating women;

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
Pregnant or lactating women;
Beschreibung

Pregnant or lactating women;

Datentyp

boolean

Alias
UMLS CUI-1
C2828358
Currently participating in an investigational drug or another device study.
Beschreibung

Currently participating in an investigational drug or another device study.

Datentyp

boolean

Alias
UMLS CUI-1
C0422740
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
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)
Item Group
Exclusion criteria
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 [1,1])
C0522473 (UMLS CUI [1,2])
Unfractionated heparin contraindicated
Item
Contraindication to unfractionated heparin
boolean
C2825026 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
Bivalirudin contraindicated
Item
Contraindication to bivalirudin;
boolean
C0168273 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
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)
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