ID

11735

Beschreibung

The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.

Stichworte

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

28. Juli 2015

DOI

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Eligibility Criteria: Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)

Englisch

Eligibility criteria

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

Inclusion Criteria

Men and women aged 18 years or more
Beschreibung

Men and women aged 18 years or more

Datentyp

boolean

Alias
UMLS CUI-1
C0001779
with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization
Beschreibung

with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization

Datentyp

boolean

Alias
UMLS CUI-1
C0008031
with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization
Beschreibung

with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization

Datentyp

boolean

Alias
UMLS CUI-1
C0151744
Participants who are planned to undergo PCI will be the target participants
Beschreibung

Participants who are planned to undergo PCI will be the target participants

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
Elevated troponin I
Beschreibung

Elevated troponin I

Datentyp

boolean

Alias
UMLS CUI-1
C0920210
creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)
Beschreibung

creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)

Datentyp

boolean

Alias
UMLS CUI-1
C0523584
ST segment depression >= 0.1 mV (>=1 mm)
Beschreibung

ST segment depression >= 0.1 mV (>=1 mm)

Datentyp

boolean

Alias
UMLS CUI-1
C0520887
transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads
Beschreibung

transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads

Datentyp

boolean

Alias
UMLS CUI-1
C0520886
Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
Beschreibung

Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.

Datentyp

boolean

Alias
UMLS CUI-1
C0021430
Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.
Beschreibung

Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.

Datentyp

boolean

Alias
UMLS CUI-1
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
Beschreibung

Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)

Datentyp

boolean

Alias
UMLS CUI-1
C0549206
known hypersensitivity to any component of the current investigational product;
Beschreibung

known hypersensitivity to any component of the current investigational product;

Datentyp

boolean

Alias
UMLS CUI-1
C0013182
Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
Beschreibung

Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C0422740
History of a bleeding diathesis
Beschreibung

History of a bleeding diathesis

Datentyp

boolean

Alias
UMLS CUI-1
C3251812
evidence of active abnormal bleeding within 30 days before enrollment
Beschreibung

evidence of active abnormal bleeding within 30 days before enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C0019080
History of a hemorrhagic stroke at any time
Beschreibung

History of a hemorrhagic stroke at any time

Datentyp

boolean

Alias
UMLS CUI-1
C0559159
Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
Beschreibung

Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;

Datentyp

boolean

Alias
UMLS CUI-1
C0020538
Major surgery within 2 weeks prior to enrollment
Beschreibung

Major surgery within 2 weeks prior to enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C0679637
Known platelet count <100,000/mm^3
Beschreibung

Known platelet count <100,000/mm^3

Datentyp

boolean

Alias
UMLS CUI-1
C0032181
Uncontrolled cardiac arrhythmia;
Beschreibung

Uncontrolled cardiac arrhythmia;

Datentyp

boolean

Alias
UMLS CUI-1
C0003811
Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease;
Beschreibung

Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease;

Datentyp

boolean

Alias
UMLS CUI-1
C0035078
Active or chronic hepatobiliary or hepatic disease
Beschreibung

Active or chronic hepatobiliary or hepatic disease

Datentyp

boolean

Alias
UMLS CUI-1
C0085605
Anticipated staged PCI
Beschreibung

Anticipated staged PCI

Datentyp

boolean

Alias
UMLS CUI-1
C1532338
Anticipated intracoronary brachytherapy
Beschreibung

Anticipated intracoronary brachytherapy

Datentyp

boolean

Alias
UMLS CUI-1
N
Concurrent or anticipated treatment with warfarin
Beschreibung

Concurrent or anticipated treatment with warfarin

Datentyp

boolean

Alias
UMLS CUI-1
C0043031
Concurrent or anticipated treatment with factor Xa inhibitor after enrollment
Beschreibung

Concurrent or anticipated treatment with factor Xa inhibitor after enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C2825027
Concurrent or anticipated treatment with direct thrombin inhibitor after enrollment
Beschreibung

Concurrent or anticipated treatment with direct thrombin inhibitor after enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C3536847
Concurrent or anticipated treatment with or antiplatelet agents after enrollment
Beschreibung

Concurrent or anticipated treatment with or antiplatelet agents after enrollment

Datentyp

boolean

Alias
UMLS CUI-1
C1096021
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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
Age
Item
Men and women aged 18 years or more
boolean
C0001779 (UMLS CUI-1)
Chest pain
Item
with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization
boolean
C0008031 (UMLS CUI-1)
Myocardial Ischemia
Item
with history of cardiac ischemia related chest discomfort of > 10 minutes duration < 24 hours prior to randomization
boolean
C0151744 (UMLS CUI-1)
PCI
Item
Participants who are planned to undergo PCI will be the target participants
boolean
C1532338 (UMLS CUI-1)
Troponin I
Item
Elevated troponin I
boolean
C0920210 (UMLS CUI-1)
CK-MB
Item
creatinine kinase MB isozyme greater than the site's upper limit of normal (ULN)
boolean
C0523584 (UMLS CUI-1)
ST-segment depression
Item
ST segment depression >= 0.1 mV (>=1 mm)
boolean
C0520887 (UMLS CUI-1)
ST-segment elevation
Item
transient (<30 minutes) ST segment elevation >= 0.1 mV (>=1 mm) in at least 2 contiguous leads
boolean
C0520886 (UMLS CUI-1)
Informed consent
Item
Willing to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and all visit schedules.
boolean
C0021430 (UMLS CUI-1)
Contraception
Item
Women of child-bearing potential (all postmenarchal women who are <1 years menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception while receiving protocol-specified medication, and for 60 days after stopping the medication.
boolean
C0700589 (UMLS CUI-1)
Item Group
Exclusion Criteria
Pregnancy
Item
Pregnant and nursing mothers (premenopausal women should have a negative pregnancy test result confirmed before enrollment)
boolean
C0549206 (UMLS CUI-1)
Medication allergy
Item
known hypersensitivity to any component of the current investigational product;
boolean
C0013182 (UMLS CUI-1)
Study patient
Item
Participation in a study of experimental therapy or use of any investigational drug within 30 days before enrollment
boolean
C0422740 (UMLS CUI-1)
Bleeding risk
Item
History of a bleeding diathesis
boolean
C3251812 (UMLS CUI-1)
Hemorrhage
Item
evidence of active abnormal bleeding within 30 days before enrollment
boolean
C0019080 (UMLS CUI-1)
History of stroke
Item
History of a hemorrhagic stroke at any time
boolean
C0559159 (UMLS CUI-1)
Hypertension
Item
Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) while receiving therapy;
boolean
C0020538 (UMLS CUI-1)
Major surgery
Item
Major surgery within 2 weeks prior to enrollment
boolean
C0679637 (UMLS CUI-1)
Platelet count
Item
Known platelet count <100,000/mm^3
boolean
C0032181 (UMLS CUI-1)
Cardiac arrhythmia
Item
Uncontrolled cardiac arrhythmia;
boolean
C0003811 (UMLS CUI-1)
Kidney failure
Item
Known impairment of renal function (serum creatinine >2.0 mg/dL [>176.8 umol/L]), dysproteinemia, nephrotic syndrome, or other renal disease;
boolean
C0035078 (UMLS CUI-1)
Liver failure
Item
Active or chronic hepatobiliary or hepatic disease
boolean
C0085605 (UMLS CUI-1)
PCI
Item
Anticipated staged PCI
boolean
C1532338 (UMLS CUI-1)
Intracoronary brachytherapy
Item
Anticipated intracoronary brachytherapy
boolean
N (UMLS CUI-1)
Warfarin
Item
Concurrent or anticipated treatment with warfarin
boolean
C0043031 (UMLS CUI-1)
Factor Xa inhibitor
Item
Concurrent or anticipated treatment with factor Xa inhibitor after enrollment
boolean
C2825027 (UMLS CUI-1)
Direct thrombin inhibitor
Item
Concurrent or anticipated treatment with direct thrombin inhibitor after enrollment
boolean
C3536847 (UMLS CUI-1)
Antiplatelet therapy
Item
Concurrent or anticipated treatment with or antiplatelet agents after enrollment
boolean
C1096021 (UMLS CUI-1)
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