ID

11732

Description

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).

Keywords

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

July 28, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Criteria: Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

Eligibility criteria

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

Inclusion Criteria

Provision of signed informed consent
Description

Provision of signed informed consent

Data type

boolean

Alias
UMLS CUI-1
C0021430
Index event of ST segment elevation ACS
Description

Index event of non-ST or ST segment elevation ACS

Data type

boolean

Alias
UMLS CUI-1
C1536220
Index event of non-ST segment elevation ACS
Description

Index event of non-ST segment elevation ACS

Data type

boolean

Alias
UMLS CUI-1
C3537184
Exclusion criteria
Description

Exclusion criteria

Index event is an acute complication of percutaneous coronary intervention
Description

Index event is an acute complication of percutaneous coronary intervention

Data type

boolean

Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
Description

Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment

Data type

boolean

Alias
UMLS CUI-1
C1532338
Oral anticoagulation therapy that cannot be stopped
Description

Oral anticoagulation therapy that cannot be stopped

Data type

boolean

Alias
UMLS CUI-1
C0003281
The conditions associated with increased risk of bradycardiac events
Description

The conditions associated with increased risk of bradycardiac events

Data type

boolean

Alias
UMLS CUI-1
C0428977

Similar models

Eligibility criteria

  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Informed consent
Item
Provision of signed informed consent
boolean
C0021430 (UMLS CUI-1)
STEMI
Item
Index event of ST segment elevation ACS
boolean
C1536220 (UMLS CUI-1)
NSTEMI
Item
Index event of non-ST segment elevation ACS
boolean
C3537184 (UMLS CUI-1)
Item Group
Exclusion criteria
PCI complication
Item
Index event is an acute complication of percutaneous coronary intervention
boolean
PCI
Item
Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
boolean
C1532338 (UMLS CUI-1)
anticoagulation therapy
Item
Oral anticoagulation therapy that cannot be stopped
boolean
C0003281 (UMLS CUI-1)
Bradycardia
Item
The conditions associated with increased risk of bradycardiac events
boolean
C0428977 (UMLS CUI-1)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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