ID

11719

Beschreibung

The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux. https://clinicaltrials.gov/ct2/show/NCT00790907

Link

https://clinicaltrials.gov/ct2/show/NCT00790907

Stichworte

Versionen (1)
  1. 28.07.15 28.07.15 -
Hochgeladen am

28. Juli 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility FUTURA/OASIS 8 Acute Coronary Syndrome NCT00790907

Englisch

Eligibility Criteria

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

Inclusion Criteria

Presenting or admitted to hospital with symptoms suspected to represent UA
Beschreibung

Presenting or admitted to hospital with symptoms suspected to represent UA

Datentyp

boolean

Alias
UMLS CUI-1
C0002965
Presenting or admitted to hospital with symptoms suspected to represent NSTEMI
Beschreibung

Presenting or admitted to hospital with symptoms suspected to represent NSTEMI

Datentyp

boolean

Alias
UMLS CUI-1
C3537184
Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
Beschreibung

Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.

Datentyp

boolean

Alias
UMLS CUI-1
C0085532
Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
Beschreibung

Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
Age greater than or equal to 60 years
Beschreibung

Age greater than or equal to 60 years

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
Troponin T above the upper limit of normal for the local institution;
Beschreibung

Troponin T above the upper limit of normal for the local institution;

Datentyp

boolean

Alias
UMLS CUI-1
C1141947
Troponin I above the upper limit of normal for the local institution;
Beschreibung

Troponin I above the upper limit of normal for the local institution;

Datentyp

boolean

Alias
UMLS CUI-1
C0920210
CK-MB above the upper limit of normal for the local institution;
Beschreibung

CK-MB above the upper limit of normal for the local institution;

Datentyp

boolean

Alias
UMLS CUI-1
C0523584
Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads
Beschreibung

Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads

Datentyp

boolean

Alias
UMLS CUI-1
C0520887
Electrocardiogram (ECG) changes compatible with ischemia, i.e., T wave inversion > 3 mm
Beschreibung

Electrocardiogram (ECG) changes compatible with ischemia, i.e., T wave inversion > 3 mm

Datentyp

boolean

Alias
UMLS CUI-1
C0520888
Electrocardiogram (ECG) changes compatible with ischemia, i.e., or any dynamic ST shift or transient ST elevation
Beschreibung

Electrocardiogram (ECG) changes compatible with ischemia, i.e., or any dynamic ST shift or transient ST elevation

Datentyp

boolean

Alias
UMLS CUI-1
C0520886
Written informed consent dated and signed
Beschreibung

Written informed consent dated and signed

Datentyp

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Age < 21 years
Beschreibung

Age < 21 years

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
Any contraindication to UFH
Beschreibung

Any contraindication to UFH

Datentyp

boolean

Alias
UMLS CUI-1
C2825026
UMLS CUI-2
C0522473
Any contraindication to fondaparinux
Beschreibung

Any contraindication to fondaparinux

Datentyp

boolean

Alias
UMLS CUI-1
C1098510
UMLS CUI-2
C0522473
Contraindication for angiography or PCI at baseline
Beschreibung

Contraindication for angiography or PCI at baseline

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
UMLS CUI-2
C0522473
Contraindication for angiography at baseline
Beschreibung

Contraindication for angiography at baseline

Datentyp

boolean

Alias
UMLS CUI-1
C0085532
UMLS CUI-2
C0522473
refractory or recurrent angina associated with dynamic ST-deviation
Beschreibung

refractory or recurrent angina associated with dynamic ST-deviation

Datentyp

boolean

Alias
UMLS CUI-1
C0002962
heart failure
Beschreibung

heart failure

Datentyp

boolean

Alias
UMLS CUI-1
C0018801
life-threatening arrhythmias
Beschreibung

life-threatening arrhythmias

Datentyp

boolean

Alias
UMLS CUI-1
C0085612
hemodynamic instability
Beschreibung

hemodynamic instability

Datentyp

boolean

Alias
UMLS CUI-1
C0948268
Subjects already receiving treatment with enoxaparin for treatment of the qualifying events
Beschreibung

Subjects already receiving treatment with enoxaparin for treatment of the qualifying events

Datentyp

boolean

Alias
UMLS CUI-1
C0206460
Subjects already receiving treatment with LMWH for treatment of the qualifying events
Beschreibung

Subjects already receiving treatment with LMWH for treatment of the qualifying events

Datentyp

boolean

Alias
UMLS CUI-1
C3536766
Subjects already receiving treatment with bivalirudin for treatment of the qualifying events
Beschreibung

Subjects already receiving treatment with bivalirudin for treatment of the qualifying events

Datentyp

boolean

Alias
UMLS CUI-1
C0168273
Subjects already receiving treatment with UFH for treatment of the qualifying events
Beschreibung

Subjects already receiving treatment with UFH for treatment of the qualifying events

Datentyp

boolean

Alias
UMLS CUI-1
C2825026
Hemorrhagic stroke within the last 12 months.
Beschreibung

Hemorrhagic stroke within the last 12 months.

Datentyp

boolean

Alias
UMLS CUI-1
C0559159
Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
Beschreibung

Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.

Datentyp

boolean

Alias
UMLS CUI-1
C0003281
Pregnancy or women of childbearing potential who are not using an effective method of contraception.
Beschreibung

Pregnancy or women of childbearing potential who are not using an effective method of contraception.

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
Co-morbid condition with life expectancy less than 6 months.
Beschreibung

Co-morbid condition with life expectancy less than 6 months.

Datentyp

boolean

Alias
UMLS CUI-1
C0679247
Currently receiving an experimental pharmacological agent.
Beschreibung

Currently receiving an experimental pharmacological agent.

Datentyp

boolean

Alias
UMLS CUI-1
C0304229
Revascularization procedure already performed for the qualifying event.
Beschreibung

Revascularization procedure already performed for the qualifying event.

Datentyp

boolean

Alias
UMLS CUI-1
C0027056
Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
Beschreibung

Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)

Datentyp

boolean

Alias
UMLS CUI-1
C1533077
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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
Unstable angina
Item
Presenting or admitted to hospital with symptoms suspected to represent UA
boolean
C0002965 (UMLS CUI-1)
NSTEMI
Item
Presenting or admitted to hospital with symptoms suspected to represent NSTEMI
boolean
C3537184 (UMLS CUI-1)
Coronary angiography
Item
Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
boolean
C0085532 (UMLS CUI-1)
PCI
Item
Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
boolean
C1532338 (UMLS CUI-1)
Age
Item
Age greater than or equal to 60 years
boolean
C0001779 (UMLS CUI-1)
Troponin T
Item
Troponin T above the upper limit of normal for the local institution;
boolean
C1141947 (UMLS CUI-1)
Troponin I
Item
Troponin I above the upper limit of normal for the local institution;
boolean
C0920210 (UMLS CUI-1)
CK-MB
Item
CK-MB above the upper limit of normal for the local institution;
boolean
C0523584 (UMLS CUI-1)
ST depression
Item
Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads
boolean
C0520887 (UMLS CUI-1)
T wave inversion
Item
Electrocardiogram (ECG) changes compatible with ischemia, i.e., T wave inversion > 3 mm
boolean
C0520888 (UMLS CUI-1)
ST elevation
Item
Electrocardiogram (ECG) changes compatible with ischemia, i.e., or any dynamic ST shift or transient ST elevation
boolean
C0520886 (UMLS CUI-1)
Informed consent
Item
Written informed consent dated and signed
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
Age
Item
Age < 21 years
boolean
C0001779 (UMLS CUI-1)
Heparin contraindicated
Item
Any contraindication to UFH
boolean
C2825026 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
Fondaparinux contraindicated
Item
Any contraindication to fondaparinux
boolean
C1098510 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
PCI contraindicated
Item
Contraindication for angiography or PCI at baseline
boolean
C1532338 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
Angiography contraindicated
Item
Contraindication for angiography at baseline
boolean
C0085532 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
Angina pectoris
Item
refractory or recurrent angina associated with dynamic ST-deviation
boolean
C0002962 (UMLS CUI-1)
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI-1)
Ventricular arrhythmia
Item
life-threatening arrhythmias
boolean
C0085612 (UMLS CUI-1)
Hemodynamic instability
Item
hemodynamic instability
boolean
C0948268 (UMLS CUI-1)
Enoxaparin
Item
Subjects already receiving treatment with enoxaparin for treatment of the qualifying events
boolean
C0206460 (UMLS CUI-1)
LMWH
Item
Subjects already receiving treatment with LMWH for treatment of the qualifying events
boolean
C3536766 (UMLS CUI-1)
Bivalirudin
Item
Subjects already receiving treatment with bivalirudin for treatment of the qualifying events
boolean
C0168273 (UMLS CUI-1)
Unfractionated heparin
Item
Subjects already receiving treatment with UFH for treatment of the qualifying events
boolean
C2825026 (UMLS CUI-1)
History of stroke
Item
Hemorrhagic stroke within the last 12 months.
boolean
C0559159 (UMLS CUI-1)
Anticoagulation therapy
Item
Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
boolean
C0003281 (UMLS CUI-1)
Pregnancy
Item
Pregnancy or women of childbearing potential who are not using an effective method of contraception.
boolean
C0549206 (UMLS CUI-1)
Terminal illness
Item
Co-morbid condition with life expectancy less than 6 months.
boolean
C0679247 (UMLS CUI-1)
Experimental drug
Item
Currently receiving an experimental pharmacological agent.
boolean
C0304229 (UMLS CUI-1)
Myocardial Revascularization
Item
Revascularization procedure already performed for the qualifying event.
boolean
C0027056 (UMLS CUI-1)
Renal failure
Item
Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
boolean
C1533077 (UMLS CUI-1)
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