ID

11735

Descripción

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.

Palabras clave

Versiones (2)
  1. 28/7/15 28/7/15 -
  2. 21/11/15 21/11/15 -
Subido en

28 de julio de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Eligibility criteria

1 formularios  
  1. StudyEvent: ODM
    1. Eligibility criteria
Inclusion Criteria
Descripción

Inclusion Criteria

Men and women aged 18 years or more
Descripción

Men and women aged 18 years or more

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Alias
UMLS CUI-1
C1532338
Elevated troponin I
Descripción

Elevated troponin I

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

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.

Tipo de datos

boolean

Alias
UMLS CUI-1
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

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

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

Tipo de datos

boolean

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

known hypersensitivity to any component of the current investigational product;

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

History of a bleeding diathesis

Tipo de datos

boolean

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

evidence of active abnormal bleeding within 30 days before enrollment

Tipo de datos

boolean

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

History of a hemorrhagic stroke at any time

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

Major surgery within 2 weeks prior to enrollment

Tipo de datos

boolean

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

Known platelet count <100,000/mm^3

Tipo de datos

boolean

Alias
UMLS CUI-1
C0032181
Uncontrolled cardiac arrhythmia;
Descripción

Uncontrolled cardiac arrhythmia;

Tipo de datos

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;
Descripción

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

Tipo de datos

boolean

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

Active or chronic hepatobiliary or hepatic disease

Tipo de datos

boolean

Alias
UMLS CUI-1
C0085605
Anticipated staged PCI
Descripción

Anticipated staged PCI

Tipo de datos

boolean

Alias
UMLS CUI-1
C1532338
Anticipated intracoronary brachytherapy
Descripción

Anticipated intracoronary brachytherapy

Tipo de datos

boolean

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

Concurrent or anticipated treatment with warfarin

Tipo de datos

boolean

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

Concurrent or anticipated treatment with factor Xa inhibitor after enrollment

Tipo de datos

boolean

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

Concurrent or anticipated treatment with direct thrombin inhibitor after enrollment

Tipo de datos

boolean

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

Concurrent or anticipated treatment with or antiplatelet agents after enrollment

Tipo de datos

boolean

Alias
UMLS CUI-1
C1096021
Volver a la parte superior de la página

Similar models

Eligibility criteria

1 formularios
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial