Coronary Artery DiseaseNCT02209909
Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
A study testing aspirin continuation and aspirin discontinuation in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- aspirin continuation and aspirin discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age : 20-80
- elective OPCAB
- informed consent
Who cannot join
- coagulation disorder
- emergency operation, re-operation
- co-existing valvular disease
- less than 6 months after cerebral vascular accident
- heparin induced thrombocytopenia
- heparin resistance
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- menstrual phase
- preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
- less than 12 months after myocardiac infarction
- less than 10 days after unstable angina
- less than 30 days after percutaneous coronary intervention
- less than 6 wks after bare metal stent insertion
- less than 12 months after drug eluting stent insertion
Trial locations and contacts
1 site in 1 country.
About this study
Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.
Read the detailed description
Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.
Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.
- Conditions
- Coronary Artery Disease
- Being tested
- aspirin continuation, aspirin discontinuation
- Keywords
- preoperative aspirin use, platelet activation, off pump coronary artery bypass
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin continuationDrug
Also called Low-dose aspirin (< 100mg/day)
Patients are randomized to continue aspirin before OPCAB surgery.
aspirin discontinuationDrug
Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.
| Study group | Role | What they receive |
|---|---|---|
| aspirin continuation | Experimental | Intervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group. Receives: Drug: aspirin continuation |
| aspirin discontinuation | Experimental | Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group. Receives: Drug: aspirin discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in platelet p-selectin at 48 hours after operation
Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.
Measured: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Secondary outcomes (1)
change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation
prothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen
Measured: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJul 2014
- 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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209909
- Sponsor's protocol ID
- OPCAB_ASA_PLT activation
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2014
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT02209909
- Acronym / sponsor ID
- OPCAB_ASA_PLT activation
- Conditions
- Coronary Artery Disease
- Keywords
- preoperative aspirin use, platelet activation, off pump coronary artery bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Aug 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.
Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.
Detailed description
Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.
Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspirin continuation | Experimental | Drug: aspirin continuationIntervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group. |
| aspirin discontinuation | Experimental | Drug: aspirin discontinuationIntervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age : 20-80
- elective OPCAB
- informed consent
Key exclusion criteria (13 listed)
- coagulation disorder
- emergency operation, re-operation
- co-existing valvular disease
- less than 6 months after cerebral vascular accident
- heparin induced thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin continuationAlso: Low-dose aspirin (< 100mg/day)Patients are randomized to continue aspirin before OPCAB surgery. | Drug | aspirin continuation |
| aspirin discontinuationPatients are randomized to discontinue aspirin more than 4 days before OPCAB surgery. | Drug | aspirin discontinuation |
Primary outcome
change from baseline in platelet p-selectin at 48 hours after operation
Time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.
1 secondary outcome
change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation
Time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation
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 21 Apr 2016.
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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.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin continuation and aspirin discontinuation in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 13 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 21 Apr 2016. 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 South Korea. 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?
change from baseline in platelet p-selectin at 48 hours after operation (time frame: after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation). 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 21 Apr 2016.