ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
1 other identifier
observational
400
1 country
2
Brief Summary
It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 24, 2016
February 1, 2016
1.6 years
March 26, 2013
February 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ASPItest
Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)
at day 3 and 5 after the first dose of aspirin following surgery
Secondary Outcomes (5)
TRAPtest
at day 3 and 5 after the first dose of aspirin following surgery
Platelet Count
at day 3 and 5 after the first dose of aspirin following surgery
Mortality
12 month
Myocardial infarction
12 month
Readmission to hospital
12 month
Other Outcomes (10)
Age
at the day of enrollment
Height
at the day of enrollment
Weight
at the day of enrollment
- +7 more other outcomes
Study Arms (1)
CABG Patients
Patients undergoing surgery for coronary revascularization.
Eligibility Criteria
Patients following cardiac surgery and a antiaggregatory therapy with aspirin
You may qualify if:
- Patients older than 18 years after cardiac surgery
- Antiaggregatory therapy with aspirin postoperatively
You may not qualify if:
- known allergy to aspirin
- need for an antiaggregatory therapy other than aspirin
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Goethe Universitylead
- University Hospital Goettingencollaborator
Study Sites (2)
Goethe - University
Frankfurt am Main, Hesse, 60590, Germany
University Hospital Goettingen
Göttingen, Lower Saxony, 37073, Germany
Related Publications (1)
Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.
PMID: 23121439BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Christian F Weber, MD
Goethe University Frankfurt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med. Dr.med. habil Christian F. Weber
Study Record Dates
First Submitted
March 26, 2013
First Posted
April 4, 2013
Study Start
August 1, 2013
Primary Completion
March 1, 2015
Study Completion
August 1, 2015
Last Updated
February 24, 2016
Record last verified: 2016-02