Acute Coronary SyndromeNCT02030548
Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy
An observational study of Acute Coronary Syndrome, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 144 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to Nov 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients undergoing acute CABG with or without valve during dual antiplatelet therapy
Who may be able to join
- consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy
Who cannot join
- concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Anesthesiology and Intensive Care Medicine
Graz, Styria, 8036
About this study
Official title: Bleeding in Patients Undergoing Urgent CABG During Dual Antiplatelet Therapy Including the New P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor
The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)
- Conditions
- Acute Coronary Syndrome
- Keywords
- CABG, dual antiplatelet therapy, aspirin, clopidogrel, prasugrel, ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
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 |
|---|---|---|
| acute CABG | patients undergoing acute CABG with or without valve replacement during dual antiplatelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculated blood loss
Measured: until postoperative day 5
Secondary outcomes (1)
mortality
Measured: from index surgery until one year after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: enrolment behind expectation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Mahla, MD, Principal investigator, Dept. of Anesthesiology and Intensive Care Medicine, MUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030548
- Sponsor's protocol ID
- NIS003684
- Status last verified
- Jun 2019
- First submitted
- 7 Jan 2014
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding in Patients Undergoing Urgent CABG During Dual Antiplatelet Therapy Including the New P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor
- ClinicalTrials.gov ID
- NCT02030548
- Acronym / sponsor ID
- NIS003684
- Conditions
- Acute Coronary Syndrome
- Keywords
- CABG, dual antiplatelet therapy, aspirin, clopidogrel, prasugrel, ticagrelor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enrolment behind expectation
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Jan 2014 (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.
The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute CABG | – | –patients undergoing acute CABG with or without valve replacement during dual antiplatelet therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing acute CABG with or without valve during dual antiplatelet therapy
Key inclusion criteria (1 listed)
- consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy
Key exclusion criteria (1 listed)
- concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest
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
calculated blood loss
Time frame: until postoperative day 5
1 secondary outcome
mortality
Time frame: from index surgery until one year after index surgery
Results and safety
The study was stopped early (reason given: enrolment behind expectation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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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.
Elisabeth Mahla, MD principal investigator
Dept. of Anesthesiology and Intensive Care Medicine, MUG
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 Acute Coronary Syndrome, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Jun 2019. 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 Austria. 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 was stopped early (reason given: enrolment behind expectation). Results are not available in the source record.
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?
calculated blood loss (time frame: until postoperative day 5). 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 6 Jun 2019.