ID

37192

Beschrijving

Aspirin Responsiveness and Outcome in Coronary Artery Bypass Graft (CABG) Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT01174862 In patients undergoing coronary artery bypass graft (CAGB) surgery, aspirin is commonly prescribed to prevent graft thrombosis and myocardial ischemia. However, there are still a significant number of grafts occluding in the postoperative period. This is partly attributed to reduced aspirin responsiveness, also called "aspirin resistance". At the moment, no standardized definition or laboratory test is available to quantify "aspirin resistance", and strong platelet reactivity in laboratory tests is not necessarily associated with increased thrombotic events. However, there is increasing evidence that reduced aspirin responsiveness in platelet function analyzers is associated with adverse long-term outcome and higher incidence of major adverse events in patients with stable coronary artery disease and in patients undergoing percutaneous coronary intervention. In patients undergoing coronary artery bypass graft surgery, the predictive value of a laboratory finding of reduced aspirin responsiveness remains unclear. Therefore, the aim of this study is to prospectively evaluate whether the pre- and/or postoperative laboratory finding of reduced aspirin responsiveness defined by MultiplateTM platelet function analyzer is associated with higher incidences of adverse outcome after 30 days and 12 months in patients undergoing CABG surgery.

Link

https://clinicaltrials.gov/show/NCT01174862

Trefwoorden

  1. 2019-07-07 2019-07-07 -
Houder van rechten

University Hospital, Basel, Switzerland

Geüploaded op

7 juli 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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Aspirin Responsiveness and Coronary Artery Bypass Graft NCT01174862

Eligibility Criteria

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

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant undergoing elective CABG surgery?
Beschrijving

CABG surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C0010055
Did the participant have therapy with aspirin until at least 2 days before surgery?
Beschrijving

Aspirin therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C3810854
UMLS CUI [1,3]
C4255413
Does the participant give written informed consent?
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant missing written consent?
Beschrijving

Missing written consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0009797
Does the participant have no therapy with aspirin or therapy stopped more than 2 days before surgery?
Beschrijving

Aspirin therapy insufficient

Datatype

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C4303556
UMLS CUI [2,1]
C4303556
UMLS CUI [2,2]
C0419823
UMLS CUI [2,3]
C0445204
UMLS CUI [2,4]
C4018905
therapy with clopidogrel more than 3 days before surgery
Beschrijving

Clopidogrel treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C3810854
UMLS CUI [1,3]
C4255413
Does the participant have emergency surgery?
Beschrijving

Emergency surgery

Datatype

boolean

Alias
UMLS CUI [1]
C4264510
Does the surgery including more than CABG?
Beschrijving

More than CABG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0010055
Does the participant have inborn or acquired platelet disorders?
Beschrijving

Platelet disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744681
UMLS CUI [1,2]
C0005818
UMLS CUI [2]
C0398636
Does the participant have therapy with selective serotonin reuptake inhibitors (SSRI)?
Beschrijving

SSRI therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0360105
Does the participant have severe hepatopathy (spontaneous quick <70%)?
Beschrijving

Severe Hepatopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0086890
Does the participant have severe kidney disease (creatinine clearance < 30 ml/min)?
Beschrijving

Severe kidney disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0022658

Similar models

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
CABG surgery
Item
Is the participant undergoing elective CABG surgery?
boolean
C0206058 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Aspirin therapy
Item
Did the participant have therapy with aspirin until at least 2 days before surgery?
boolean
C0004057 (UMLS CUI [1,1])
C3810854 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,3])
Informed Consent
Item
Does the participant give written informed consent?
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Missing written consent
Item
Is the participant missing written consent?
boolean
C1705492 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Aspirin therapy insufficient
Item
Does the participant have no therapy with aspirin or therapy stopped more than 2 days before surgery?
boolean
C1705492 (UMLS CUI [1,1])
C4303556 (UMLS CUI [1,2])
C4303556 (UMLS CUI [2,1])
C0419823 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C4018905 (UMLS CUI [2,4])
Clopidogrel treatment
Item
therapy with clopidogrel more than 3 days before surgery
boolean
C0070166 (UMLS CUI [1,1])
C3810854 (UMLS CUI [1,2])
C4255413 (UMLS CUI [1,3])
Emergency surgery
Item
Does the participant have emergency surgery?
boolean
C4264510 (UMLS CUI [1])
More than CABG
Item
Does the surgery including more than CABG?
boolean
C0543467 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
Platelet disorders
Item
Does the participant have inborn or acquired platelet disorders?
boolean
C1744681 (UMLS CUI [1,1])
C0005818 (UMLS CUI [1,2])
C0398636 (UMLS CUI [2])
SSRI therapy
Item
Does the participant have therapy with selective serotonin reuptake inhibitors (SSRI)?
boolean
C0360105 (UMLS CUI [1])
Severe Hepatopathy
Item
Does the participant have severe hepatopathy (spontaneous quick <70%)?
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0086890 (UMLS CUI [2])
Severe kidney disease
Item
Does the participant have severe kidney disease (creatinine clearance < 30 ml/min)?
boolean
C0205082 (UMLS CUI [1,1])
C0022658 (UMLS CUI [1,2])

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