ID

12475

Beschrijving

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01156571

Link

https://clinicaltrials.gov/ct2/show/NCT01156571

Trefwoorden

  1. 21-11-15 21-11-15 -
Geüploaded op

21 november 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility CHAMPION PHOENIX Acute Coronary Syndrome NCT01156571

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Inclusion Criteria
Beschrijving

Inclusion Criteria

Male or non-pregnant female
Beschrijving

Male or non-pregnant female

Datatype

boolean

Alias
UMLS CUI-1
C0079399
non-pregnant female
Beschrijving

non-pregnant female

Datatype

boolean

Alias
UMLS CUI-1
C0549206
at least 18 years of age
Beschrijving

at least 18 years of age

Datatype

boolean

Alias
UMLS CUI-1
C0001779
Patients undergoing percutaneous coronary intervention (PCI)
Beschrijving

Patients undergoing percutaneous coronary intervention (PCI)

Datatype

boolean

Alias
UMLS CUI-1
C1532338
Stable angina (SA) patients
Beschrijving

Stable angina (SA) patients

Datatype

boolean

Alias
UMLS CUI-1
C0002962
with diagnostic coronary angiography
Beschrijving

with diagnostic coronary angiography

Datatype

boolean

Alias
UMLS CUI-1
C0085532
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
Beschrijving

Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis

Datatype

boolean

Alias
UMLS CUI-1
C3537184
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
Beschrijving

Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis

Datatype

boolean

Alias
UMLS CUI-1
C0948089
ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
Beschrijving

ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)

Datatype

boolean

Alias
UMLS CUI-1
C1536220
Provide written informed consent
Beschrijving

Provide written informed consent

Datatype

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
Beschrijving

Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization

Datatype

boolean

Alias
UMLS CUI-1
C2936588
Eptifibatide usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
Beschrijving

Eptifibatide usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)

Datatype

boolean

Alias
UMLS CUI-1
C0253563
Tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
Beschrijving

Tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)

Datatype

boolean

Alias
UMLS CUI-1
C0247025
Abciximab usage within 7 days preceding randomization
Beschrijving

Abciximab usage within 7 days preceding randomization

Datatype

boolean

Alias
UMLS CUI-1
C0288672
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Beschrijving

Receipt of fibrinolytic therapy in the 12 hours preceding randomization

Datatype

boolean

Alias
UMLS CUI-1
C0040044
Increased bleeding risk
Beschrijving

Increased bleeding risk

Datatype

boolean

Alias
UMLS CUI-1
C3251812
ischemic stroke within the last year or any previous hemorrhagic stroke
Beschrijving

ischemic stroke within the last year or any previous hemorrhagic stroke

Datatype

boolean

Alias
UMLS CUI-1
C0038454
tumor
Beschrijving

tumor

Datatype

boolean

Alias
UMLS CUI-1
C0006826
cerebral arteriovenous malformation
Beschrijving

cerebral arteriovenous malformation

Datatype

boolean

Alias
UMLS CUI-1
C0003857
intracranial aneurysm
Beschrijving

intracranial aneurysm

Datatype

boolean

Alias
UMLS CUI-1
C0007766
recent (<1 month) trauma
Beschrijving

recent (<1 month) trauma

Datatype

boolean

Alias
UMLS CUI-1
C3263723
major surgery (including bypass surgery)
Beschrijving

major surgery (including bypass surgery)

Datatype

boolean

Alias
UMLS CUI-1
C0679637
currently receiving warfarin
Beschrijving

currently receiving warfarin

Datatype

boolean

Alias
UMLS CUI-1
C0043031
active bleeding
Beschrijving

active bleeding

Datatype

boolean

Alias
UMLS CUI-1
C0019080

Similar models

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
Gender
Item
Male or non-pregnant female
boolean
C0079399 (UMLS CUI-1)
Pregnancy
Item
non-pregnant female
boolean
C0549206 (UMLS CUI-1)
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI-1)
PCI
Item
Patients undergoing percutaneous coronary intervention (PCI)
boolean
C1532338 (UMLS CUI-1)
Angina pectoris
Item
Stable angina (SA) patients
boolean
C0002962 (UMLS CUI-1)
Coronary angiography
Item
with diagnostic coronary angiography
boolean
C0085532 (UMLS CUI-1)
NSTEMI
Item
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
boolean
C3537184 (UMLS CUI-1)
Acute coronary syndrome
Item
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
boolean
C0948089 (UMLS CUI-1)
STEMI
Item
ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
boolean
C1536220 (UMLS CUI-1)
Informed consent
Item
Provide written informed consent
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
Thienopyridines
Item
Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
boolean
C2936588 (UMLS CUI-1)
Eptifibatide
Item
Eptifibatide usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
boolean
C0253563 (UMLS CUI-1)
Tirofiban
Item
Tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
boolean
C0247025 (UMLS CUI-1)
Abciximab
Item
Abciximab usage within 7 days preceding randomization
boolean
C0288672 (UMLS CUI-1)
Thrombolytic Therapy
Item
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
boolean
C0040044 (UMLS CUI-1)
Bleeding risk
Item
Increased bleeding risk
boolean
C3251812 (UMLS CUI-1)
Stroke
Item
ischemic stroke within the last year or any previous hemorrhagic stroke
boolean
C0038454 (UMLS CUI-1)
Tumor
Item
tumor
boolean
C0006826 (UMLS CUI-1)
Cerebral arteriovenous malformation
Item
cerebral arteriovenous malformation
boolean
C0003857 (UMLS CUI-1)
intracranial aneurysm
Item
intracranial aneurysm
boolean
C0007766 (UMLS CUI-1)
Trauma
Item
recent (<1 month) trauma
boolean
C3263723 (UMLS CUI-1)
Major surgery
Item
major surgery (including bypass surgery)
boolean
C0679637 (UMLS CUI-1)
Warfarin
Item
currently receiving warfarin
boolean
C0043031 (UMLS CUI-1)
Hemorrhage
Item
active bleeding
boolean
C0019080 (UMLS CUI-1)

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