Coronary Artery Bypass Graft Triple VesselNCT01174862
Aspirin Responsiveness and Outcome in Coronary Artery Bypass Graft (CABG) Surgery
An observational study of Coronary Artery Bypass Graft Triple Vessel and Myocardial Ischemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Triple Vessel, Myocardial Ischemia, Thrombosis
- How many people
- 304 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Jun 2013
- 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 undergoing elective CABG surgery (on-pump and off pump surgery)
Who may be able to join
- patient undergoing elective CABG surgery
- therapy with aspirin until at least 2 days before surgery
- written informed consent
Who cannot join
- missing written consent
- no therapy with aspirin or therapy stopped more than 2 days before surgery
- therapy with clopidogrel more than 3 days before surgery
- emergency surgery
- surgery including more than CABG
- inborn or acquired platelet disorders
Show all 9Show fewer
- therapy with Selective Serotonin reuptake inhibitors (SSRI)
- severe hepatopathy (spontaneous Quick <70%)
- severe kidney disease (creatinine clearance < 30 ml/min)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesia and Intensive Care Unit, Univeristy Hospital Basel, Switzerland
Basel, Canton of Basel-City, 4031
About this study
Official title: Comparative Cohort Study on the Outcome of Patients With Normal and Reduced Acetylsalicylic Acid Responsiveness Undergoing Coronary Artery Bypass Surgery
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.
- Conditions
- Coronary Artery Bypass Graft Triple Vessel, Myocardial Ischemia, Thrombosis, Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use
- Keywords
- aspirin, aspirin responsiveness, long-term outcome, CABG
- Medical subject headings
- Myocardial Ischemia, Thrombosis
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 |
|---|---|---|
| Aspirin responder | Normal aspirin responsiveness in ASPI test (Multiplate) | |
| Aspirin non-responder | Reduced aspirin responsiveness in ASPI test (Multiplate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death and/or major cardiac or thromboembolic events
Measured: 12 months after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft Triple VesselStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bolliger, University Hospital, Basel, Switzerland
- Investigators
- Daniel Bolliger, MD, Principal investigator, Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174862
- Sponsor's protocol ID
- 288/09
- Status last verified
- Mar 2015
- First submitted
- 2 Aug 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Cohort Study on the Outcome of Patients With Normal and Reduced Acetylsalicylic Acid Responsiveness Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01174862
- Acronym / sponsor ID
- 288/09
- Conditions
- Coronary Artery Bypass Graft Triple Vessel, Myocardial Ischemia, Thrombosis, Antithrombotic Drugs [Platelet-aggregation Inhibitors] Causing Adverse Effects in Therapeutic Use
- Keywords
- aspirin, aspirin responsiveness, long-term outcome, CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Aug 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin responder | – | –Normal aspirin responsiveness in ASPI test (Multiplate) |
| Aspirin non-responder | – | –Reduced aspirin responsiveness in ASPI test (Multiplate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective CABG surgery (on-pump and off pump surgery)
Key inclusion criteria (3 listed)
- patient undergoing elective CABG surgery
- therapy with aspirin until at least 2 days before surgery
- written informed consent
Key exclusion criteria (9 listed)
- missing written consent
- no therapy with aspirin or therapy stopped more than 2 days before surgery
- therapy with clopidogrel more than 3 days before surgery
- emergency surgery
- surgery including more than CABG
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
Death and/or major cardiac or thromboembolic events
Time frame: 12 months after cardiac surgery
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 10 Mar 2015.
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.
Daniel Bolliger, MD principal investigator
Department of Anaesthesia and Intensive Care Unit, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Graft Triple Vessel and Myocardial Ischemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 9 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Death and/or major cardiac or thromboembolic events (time frame: 12 months after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.