Acute Coronary SyndromeNCT01793597
Platelet Reactivity After CABG
An observational study of Acute Coronary Syndrome, run by University of Vermont at 1 site in United States.
Trial summary
Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 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 with acute coronary syndrome who based on clinical indications require urgent CABG. CABG is scheduled for clinical indications within 48 hours. Previous treatment with clopidogrel or ticagrelor.
Who may be able to join
- Acute coronary syndrome, CABG, within 48 hours of last dose of clopidogrel or ticagrelor, treatment with aspirin
Who cannot join
- Treatment with an antiplatelet agent other than aspirin, clopidogrel, or ticagrelor, Acute or chronic hematologic disorder including a preoperative Hgb less than 10 g/dl or platelet count less than 100,000/mm3, Moderate or severe renal insufficiency (glomerular filtration rate less than 60 ml/min), Active infection, Active malignancy, Unable/unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel
Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel. The reason for this difference cannot be explained on the basis of the study. One possible explanation is that the reversible binding of ticagrelor is advantageous because when new platelets are released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot redistribute. The investigators will recruit patients who are scheduled for surgery after an acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After the patient provides informed consent, the investigators will review their medical record,record information and on the day after surgery the investigators will take one sample of blood. That blood will be analyzed for evidence of platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and the concentration of inflammatory cytokines. The investigators hypothesize that the evidence of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in patients who have been treated previously with ticagrelor.
- Conditions
- Acute Coronary Syndrome
- Keywords
- ticagrelor, Coronary artery bypass surgery, platelet function, receptor binding, platelet reactivity, reversible binding
- 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 |
|---|---|---|
| clopidogrel | previous treatment with clopidogrel | |
| ticagrelor | previous treatment with ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
reactivity of juvenile platelets
We will use flow cytometry to identify juvenile platelets and assess their likelihood to activate in response to a submaximal concentration of agonist.
Measured: 16-24 hours after CABG
Secondary outcomes (3)
platelet-leukocyte aggregates
We will identify the prevalence of platelet-leukocyte aggregates - a marker of platelet activation in vivo
Measured: 16-24 hours after CABG
platelet microparticles
We will quantify the prevalence of platelet microparticles, reflecting platelet activation in vivo
Measured: 16-24 hours after CABG
cytokine/chemokine array
We will quantify the concentration of common cytokines and chemokines.
Measured: 16-24 hours after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Schneider, MD, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793597
- Sponsor's protocol ID
- ISSBRIL0095
- Status last verified
- Sep 2015
- First submitted
- 13 Feb 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel
- ClinicalTrials.gov ID
- NCT01793597
- Acronym / sponsor ID
- ISSBRIL0095
- Conditions
- Acute Coronary Syndrome
- Keywords
- ticagrelor, Coronary artery bypass surgery, platelet function, receptor binding, platelet reactivity, reversible binding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Feb 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.
Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel. The reason for this difference cannot be explained on the basis of the study. One possible explanation is that the reversible binding of ticagrelor is advantageous because when new platelets are released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot redistribute. The investigators will recruit patients who are scheduled for surgery after an acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After the patient provides informed consent, the investigators will review their medical record,record information and on the day after surgery the investigators will take one sample of blood. That blood will be analyzed for evidence of platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and the concentration of inflammatory cytokines. The investigators hypothesize that the evidence of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in patients who have been treated previously with ticagrelor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clopidogrel | – | –previous treatment with clopidogrel |
| ticagrelor | – | –previous treatment with ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome who based on clinical indications require urgent CABG. CABG is scheduled for clinical indications within 48 hours. Previous treatment with clopidogrel or ticagrelor.
Key inclusion criteria (1 listed)
- Acute coronary syndrome, CABG, within 48 hours of last dose of clopidogrel or ticagrelor, treatment with aspirin
Key exclusion criteria (1 listed)
- Treatment with an antiplatelet agent other than aspirin, clopidogrel, or ticagrelor, Acute or chronic hematologic disorder including a preoperative Hgb less than 10 g/dl or platelet count less than 100,000/mm3, Moderate or severe renal insufficiency (glomerular filtration rate less than 60 ml/min), Active infection, Active malignancy, Unable/unwilling to provide informed consent
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
reactivity of juvenile platelets
Time frame: 16-24 hours after CABG
We will use flow cytometry to identify juvenile platelets and assess their likelihood to activate in response to a submaximal concentration of agonist.
3 secondary outcomes
platelet-leukocyte aggregates
Time frame: 16-24 hours after CABG
platelet microparticles
Time frame: 16-24 hours after CABG
cytokine/chemokine array
Time frame: 16-24 hours after CABG
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 22 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Vermont at 1 site in United States.
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: finished, as of the sponsor's last update on 22 Sep 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 United States. 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?
reactivity of juvenile platelets (time frame: 16-24 hours after CABG). 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 22 Sep 2015.