ASS-NonresponseNCT01824147
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
An observational study of ASS-Nonresponse, run by Goethe University at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASS-Nonresponse
- How many people
- 400 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients following cardiac surgery and a antiaggregatory therapy with aspirin
Who may be able to join
- Patients older than 18 years after cardiac surgery
- Antiaggregatory therapy with aspirin postoperatively
Who cannot join
- known allergy to aspirin
- need for an antiaggregatory therapy other than aspirin
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Goethe - University
Frankfurt am Main, Hesse, 60590
University Hospital Goettingen
Göttingen, Lower Saxony, 37073
About this study
It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).
Read the detailed description
Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.
- Conditions
- ASS-Nonresponse
- Keywords
- ASS-Nonresponse, cardiac, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CABG Patients | Patients undergoing surgery for coronary revascularization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASPItest
Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)
Measured: at day 3 and 5 after the first dose of aspirin following surgery
Secondary outcomes (5)
TRAPtest
Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6
Measured: at day 3 and 5 after the first dose of aspirin following surgery
Platelet Count
Platelet count taken from the daily standard laboratory results.
Measured: at day 3 and 5 after the first dose of aspirin following surgery
Mortality
Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study
Measured: 12 month
Myocardial infarction
Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.
Measured: 12 month
Readmission to hospital
Did a readmission to hospital due to cardiac or pulmonary reasons take place in the 12 month following enrollment into the study? Assessed by a telephonic follow up interview.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASS-NonresponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Goettingen
- Responsible party
- Principal investigator, Christian F. Weber, MD, Goethe University
- Investigators
- Christian F Weber, MD, Principal investigator, Goethe University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824147
- Sponsor's protocol ID
- 33/13
- Status last verified
- Feb 2016
- First submitted
- 26 Mar 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23121439
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
- ClinicalTrials.gov ID
- NCT01824147
- Acronym / sponsor ID
- 33/13
- Conditions
- ASS-Nonresponse
- Keywords
- ASS-Nonresponse, cardiac, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- University Hospital Goettingen
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).
Detailed description
Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG Patients | – | –Patients undergoing surgery for coronary revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients following cardiac surgery and a antiaggregatory therapy with aspirin
Key inclusion criteria (2 listed)
- Patients older than 18 years after cardiac surgery
- Antiaggregatory therapy with aspirin postoperatively
Key exclusion criteria (3 listed)
- known allergy to aspirin
- need for an antiaggregatory therapy other than aspirin
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ASPItest
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)
5 secondary outcomes
TRAPtest
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
Platelet Count
Time frame: at day 3 and 5 after the first dose of aspirin following surgery
Mortality
Time frame: 12 month
Myocardial infarction
Time frame: 12 month
Readmission to hospital
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Background: PubMed 23121439Collet 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian F Weber, MD principal investigator
Goethe University Frankfurt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASS-Nonresponse, run by Goethe University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASPItest (time frame: at day 3 and 5 after the first dose of aspirin following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.