ID

11733

Description

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.

Keywords

Versions (2)
  1. 7/28/15 7/28/15 -
  2. 11/21/15 11/21/15 -
Uploaded on

July 28, 2015

DOI

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License

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)

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

The patient is, male or female
Description

The patient is, male or female

Data type

boolean

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

> 18 years of age

Data type

boolean

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

The patient presents with coronary syndrome

Data type

boolean

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

The patient presents with coronary syndrome

Data type

boolean

Alias
UMLS CUI-1
C0948089
unstable angina
Description

unstable angina

Data type

boolean

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

non ST segment elevated myocardial infarction (NSTEMI)

Data type

boolean

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

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

Data type

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.
Description

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

Data type

boolean

Alias
UMLS CUI-1
C0021430
Exclusion criteria
Description

Exclusion criteria

ST elevated myocardial infarction within the preceding 48 hours
Description

ST elevated myocardial infarction within the preceding 48 hours

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Patients with known conditions of bleeding diathesis

Data type

boolean

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

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

Data type

boolean

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

Known diagnosis of acute bacterial endocarditis;

Data type

boolean

Alias
UMLS CUI-1
C0014121
Patients with cardiogenic shock
Description

Patients with cardiogenic shock

Data type

boolean

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

Required intra-aortic balloon pump (IABP)

Data type

boolean

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

If patient is on warfarin (Coumadin) therapy

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI-1
C0035078
status post renal transplant
Description

status post renal transplant

Data type

boolean

Alias
UMLS CUI-1
C0022671
patients on chronic dialysis
Description

patients on chronic dialysis

Data type

boolean

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

creatinine clearance ≤ 30 ml/min

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Known allergies to contrast that cannot be medically managed;

Data type

boolean

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

Prior angioplasty within the previous 30 days;

Data type

boolean

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

Contraindication to low-molecular weight heparin

Data type

boolean

Alias
UMLS CUI-1
C3536766
UMLS CUI-2
C0522473
UMLS CUI-3
P
Contraindication to unfractionated heparin
Description

Contraindication to unfractionated heparin

Data type

boolean

Alias
UMLS CUI-1
C2825026
UMLS CUI-2
C0522473
UMLS CUI-3
P
Contraindication to bivalirudin;
Description

Contraindication to bivalirudin;

Data type

boolean

Alias
UMLS CUI-1
C0168273
UMLS CUI-2
C0522473
UMLS CUI-3
P
Pregnant or lactating women;
Description

Pregnant or lactating women;

Data type

boolean

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

Pregnant or lactating women;

Data type

boolean

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

Currently participating in an investigational drug or another device study.

Data type

boolean

Alias
UMLS CUI-1
C0422740
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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)
Bivalirudin contraindicated
Item
Contraindication to bivalirudin;
boolean
C0168273 (UMLS CUI-1)
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)
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