Coronary Artery DiseaseNCT02293928
Impact of Hybrid Coronary Revascularization on Antiplatelet Therapy
An observational study of Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Hybrid coronary revascularization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Apr 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 with coronary artery disease scheduled for elective hybrid coronary revascularization. The study cohort is recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting and percutaneous coronary intervention (PCI) performed three to five days later (Clinicaltrials.gov identifier: NCT01496664).
Who may be able to join
- symptomatic multivessel coronary artery disease
- treatment with non-enteric coated aspirin 75 mg once daily
Who cannot join
- aspirin or clopidogrel intolerance
- conditions prohibitive of aspirin discontinuation prior to surgery
- use of anticoagulants or any drugs other than aspirin known to affect platelet function
- use of immunosuppressive drugs
- platelet count <100 or >450 x 109/l
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Hybrid Coronary Revascularization on Antiplatelet Effect of Aspirin and Clopidogrel
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
The aim of the study is to describe the impact of hybrid coronary revascularization on the effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline platelet aggregation, high postoperative levels of platelet turnover and acute-phase response may contribute to the effect.
Read the detailed description
Objective:
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
We hypothesize that hybrid coronary revascularization is associated with a transiently reduced antiplatelet effect of aspirin and clopidogrel. We hypothesize that the reduced antiplatelet effect of aspirin and clopidogrel could be explained by increased platelet turnover with an increased fraction of immature platelets in the peripheral blood. Furthermore, we hypothesize that the reduced antiplatelet effect is associated with increased inflammatory markers in the early postoperative phase. We hypothesize, that high platelet aggregation prior to the intervention is associated with reduced effect of antiplatelet therapy following hybrid coronary revascularization.
Methods:
40 patients with coronary artery disease will be enrolled in this prospective cohort study (recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting through an inferior J-hemisternotomy (JOPCAB) with percutaneous coronary intervention - Clinicaltrials.gov identifier: NCT01496664). Demographics and medical history are documented preoperatively. The predicted mortality is assessed by means of the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I. Adverse cardiovascular events are recorded prospectively, including graft dysfunction, myocardial infarction, stroke, and pulmonary embolism.
Six blood samples are obtained from each patient:
- Pre-OP: in the outpatient setting while patients were on aspirin 75 mg daily
- Baseline: in the morning prior to surgery after eight to ten days of aspirin discontinuation (off-aspirin)
- Post-OP: on the first postoperative day when aspirin had been resumed
- Pre-PCI: on the day prior to PCI
- Post-PCI: on the first day after PCI following initiation of dual antiplatelet therapy
- 1-year follow-up: when patients were still on maintenance aspirin 75 mg and clopidogrel 75 mg Platelet function analyses are performed using Multiplate® Analyzer (Roche, Roche Diagnostics, Mannheim, Germany), VerifyNow® Aspirin, and VerifyNow® P2Y12 (Accumetrics Inc., San Diego, CA, USA). For Multiplate® Analyzer, arachidonic acid (1.0 mM) and adenosine diphosphate (6.4 and 20 uM) are used as agonists.
Complete blood counts, including immature platelet fraction (IPF), immature platelet count (IPC), and mean platelet volume (MPV), are performed using a Sysmex XE-5000 haematology analyzer (Sysmex, Kobe, Japan) with upgraded software (XE IPF Master, Sysmex) enabling flow cytometric detection of the IPF. Enzyme-linked immunosorbent assays are used according to the manufacturers' instructions to measure serum thromboxane B2 (Cayman Chemical, Ann Arbor, MI, USA) and thrombopoietin (R\&D Systems Europe, Abingdon, UK). Plasma C-reactive protein was measured by immunoprecipitation using the Cobas® 6000 (Roche, Basel, Switzerland). Von Willebrand factor (antigen) and coagulation factor VIII (functional) are measured using the ACL TOP (ILS Laboratories, Bedford, MA, USA).
- Conditions
- Coronary Artery Disease
- Being tested
- Hybrid coronary revascularization
- Keywords
- Hybrid coronary revascularization, Antiplatelet therapy, Aspirin, Clopidogrel
- 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.
Hybrid coronary revascularizationProcedure or surgery
Hybrid coronary revascularization with standard double antiplatelet therapy
| Study group | Role | What they receive |
|---|---|---|
| Elective hybrid coronary revascularization | All patients are treated with non-enteric coated aspirin 75 mg once daily prior to study participation. Aspirin treatment is discontinued 8-10 days prior to surgery and resumed 6-9 hours after surgery. Left internal mammary grafting of the left descendent coronary artery is performed off-pump through an inferior J-hemisternotomy (JOPCAB). All patients receive an oral loading dose of aspirin 300 mg 6-9 hours after surgery followed by daily maintenance doses of 75 mg aspirin. An oral loading dose of clopidogrel 300 mg 12 hours prior to PCI is followed by daily maintenance doses of 75 mg for 12 months. Patients are followed for 1 year. Receives: Procedure: Hybrid coronary revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aspirin antiplatelet effect from preoperative to three days postoperative
Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer
Measured: 12-14 days
Secondary outcomes (5)
Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up
Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer
Measured: 1 year
Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up
Platelet aggregation measured by VerifyNow®P2Y12 and Multiplate® Analyzer
Measured: 1 year
Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect
Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer Baseline aggregation is compared to aggragation preoperatively (on maintenance aspirin treatment) and postoperatively (when aspirin is resumed).
Measured: 12-14 days
Correlation between acute phase reactants and platelet aggregation
C-reactive protein, von Willebrand factor (antigen), and coagulation factor VIII (functional)
Measured: 8-10 days preoperative until 1 year postoperative
Correlation between platelet turnover and platelet aggregation
Platelet turnover assessed by Complete blood counts, including immature platelet fraction, immature platelet count, mean platelet volume and thrombopoietin.
Measured: 8-10 days preoperative until 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
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 Coronary Artery DiseaseStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation, Aase and Ejnar Danielsens Foundation
- Responsible party
- Principal investigator, Ivy Modrau, Aarhus University Hospital Skejby
- Investigators
- Ivy S Modrau, MD, DMSc, Principal investigator, Aarhus University Hospitak Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293928
- Sponsor's protocol ID
- 10-000439
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Modrau IS, Wurtz M, Kristensen SD, Hvas AM. Reduced Effect of Aspirin and Clopidogrel Following Hybrid Coronary Revascularization. Clin Appl Thromb Hemost. 2015 Oct;21(7):603-11. doi: 10.1177/1076029615573304. Epub 2015 Mar 9.
PubMed 25753965
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hybrid Coronary Revascularization on Antiplatelet Effect of Aspirin and Clopidogrel
- ClinicalTrials.gov ID
- NCT02293928
- Acronym / sponsor ID
- 10-000439
- Conditions
- Coronary Artery Disease
- Keywords
- Hybrid coronary revascularization, Antiplatelet therapy, Aspirin, Clopidogrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Danish Heart Foundation, Aase and Ejnar Danielsens Foundation
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Nov 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 effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
The aim of the study is to describe the impact of hybrid coronary revascularization on the effect of aspirin and clopidogrel. Furthermore, we will investigate whether high baseline platelet aggregation, high postoperative levels of platelet turnover and acute-phase response may contribute to the effect.
Detailed description
Objective:
The effect of antiplatelet therapy is impaired among patients, who recently underwent on-pump coronary artery bypass grafting. The impact of hybrid coronary revascularization using minimal invasive surgical techniques on the antiplatelet effect of aspirin and clopidogrel remains unclear.
We hypothesize that hybrid coronary revascularization is associated with a transiently reduced antiplatelet effect of aspirin and clopidogrel. We hypothesize that the reduced antiplatelet effect of aspirin and clopidogrel could be explained by increased platelet turnover with an increased fraction of immature platelets in the peripheral blood. Furthermore, we hypothesize that the reduced antiplatelet effect is associated with increased inflammatory markers in the early postoperative phase. We hypothesize, that high platelet aggregation prior to the intervention is associated with reduced effect of antiplatelet therapy following hybrid coronary revascularization.
Methods:
40 patients with coronary artery disease will be enrolled in this prospective cohort study (recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting through an inferior J-hemisternotomy (JOPCAB) with percutaneous coronary intervention - Clinicaltrials.gov identifier: NCT01496664). Demographics and medical history are documented preoperatively. The predicted mortality is assessed by means of the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I. Adverse cardiovascular events are recorded prospectively, including graft dysfunction, myocardial infarction, stroke, and pulmonary embolism.
Six blood samples are obtained from each patient:
- Pre-OP: in the outpatient setting while patients were on aspirin 75 mg daily
- Baseline: in the morning prior to surgery after eight to ten days of aspirin discontinuation (off-aspirin)
- Post-OP: on the first postoperative day when aspirin had been resumed
- Pre-PCI: on the day prior to PCI
- Post-PCI: on the first day after PCI following initiation of dual antiplatelet therapy
- 1-year follow-up: when patients were still on maintenance aspirin 75 mg and clopidogrel 75 mg Platelet function analyses are performed using Multiplate® Analyzer (Roche, Roche Diagnostics, Mannheim, Germany), VerifyNow® Aspirin, and VerifyNow® P2Y12 (Accumetrics Inc., San Diego, CA, USA). For Multiplate® Analyzer, arachidonic acid (1.0 mM) and adenosine diphosphate (6.4 and 20 uM) are used as agonists.
Complete blood counts, including immature platelet fraction (IPF), immature platelet count (IPC), and mean platelet volume (MPV), are performed using a Sysmex XE-5000 haematology analyzer (Sysmex, Kobe, Japan) with upgraded software (XE IPF Master, Sysmex) enabling flow cytometric detection of the IPF. Enzyme-linked immunosorbent assays are used according to the manufacturers' instructions to measure serum thromboxane B2 (Cayman Chemical, Ann Arbor, MI, USA) and thrombopoietin (R\&D Systems Europe, Abingdon, UK). Plasma C-reactive protein was measured by immunoprecipitation using the Cobas® 6000 (Roche, Basel, Switzerland). Von Willebrand factor (antigen) and coagulation factor VIII (functional) are measured using the ACL TOP (ILS Laboratories, Bedford, MA, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective hybrid coronary revascularization | – | Procedure: Hybrid coronary revascularizationAll patients are treated with non-enteric coated aspirin 75 mg once daily prior to study participation. Aspirin treatment is discontinued 8-10 days prior to surgery and resumed 6-9 hours after surgery. Left internal mammary grafting of the left descendent coronary artery is performed off-pump through an inferior J-hemisternotomy (JOPCAB). All patients receive an oral loading dose of aspirin 300 mg 6-9 hours after surgery followed by daily maintenance doses of 75 mg aspirin. An oral loading dose of clopidogrel 300 mg 12 hours prior to PCI is followed by daily maintenance doses of 75 mg for 12 months. Patients are followed for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease scheduled for elective hybrid coronary revascularization. The study cohort is recruited from a prospective pilot study conducted to assess feasibility and safety of hybrid coronary revascularization combining minimally invasive off-pump coronary artery bypass grafting and percutaneous coronary intervention (PCI) performed three to five days later (Clinicaltrials.gov identifier: NCT01496664).
Key inclusion criteria (2 listed)
- symptomatic multivessel coronary artery disease
- treatment with non-enteric coated aspirin 75 mg once daily
Key exclusion criteria (6 listed)
- aspirin or clopidogrel intolerance
- conditions prohibitive of aspirin discontinuation prior to surgery
- use of anticoagulants or any drugs other than aspirin known to affect platelet function
- use of immunosuppressive drugs
- platelet count <100 or >450 x 109/l
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 |
|---|---|---|
| Hybrid coronary revascularizationHybrid coronary revascularization with standard double antiplatelet therapy | Procedure or surgery | Elective hybrid coronary revascularization |
Primary outcome
Change in aspirin antiplatelet effect from preoperative to three days postoperative
Time frame: 12-14 days
Platelet aggregation measured by VerifyNow® Aspirin and Multiplate® Analyzer
5 secondary outcomes
Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up
Time frame: 1 year
Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up
Time frame: 1 year
Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect
Time frame: 12-14 days
Correlation between acute phase reactants and platelet aggregation
Time frame: 8-10 days preoperative until 1 year postoperative
Correlation between platelet turnover and platelet aggregation
Time frame: 8-10 days preoperative until 1 year postoperative
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 19 Nov 2014.
- Derived from this study: PubMed 25753965Modrau IS, Wurtz M, Kristensen SD, Hvas AM. Reduced Effect of Aspirin and Clopidogrel Following Hybrid Coronary Revascularization. Clin Appl Thromb Hemost. 2015 Oct;21(7):603-11. doi: 10.1177/1076029615573304. Epub 2015 Mar 9.
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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.
Ivy S Modrau, MD, DMSc principal investigator
Aarhus University Hospitak Skejby
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 Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 6 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 19 Nov 2014. 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 Denmark. 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 in aspirin antiplatelet effect from preoperative to three days postoperative (time frame: 12-14 days). 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 NCT02293928, 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 19 Nov 2014.