Coronary Artery DiseaseNCT01959191
Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass
An observational study of Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design Prospective, observational, single-center… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
- How many people
- 859 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Jul 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with indications for surgical myocardial revascularization
Who may be able to join
- Patients with indications for surgical myocardial revascularization
- Patients who undergo off-pump coronary artery bypass
- Age between 19~80 years
- Patients with signed informed consent
Who cannot join
- Patients with combined surgery with coronary bypass grafting
- On-pump conversion
- Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis
- Patients with chronic treatment with proton pump inhibitors
- Patients with preoperative bleeding
- Thrombocytopenia (Platelet count 70,000/ml)
- Re-do surgery
- Early death before the measurement of platelet reactivity
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, 120-752
About this study
Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design
- Prospective, observational, single-center study
- Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled.
- Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system.
- Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint.
- Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups).
- The primary and secondary endpoints will be compared between two groups
- Conditions
- Coronary Artery Disease
- Being tested
- Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery
- Keywords
- Platelet activity, CABG, off-pump surgery
- 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.
Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgeryDrug
aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Low platelet reactivity group | Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group" Receives: Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery | |
| high platelet reactivity group | Platelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group" Receives: Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACEs)
The primary endpoint of the study was the 1-year incidence of MACEs, which included the following: (1) cardiac death, defined as death in the presence of acute coronary syndrome, sudden cardiac arrest with documented cardiac arrhythmia, or refractory congestive heart failure; 2) nonfatal MI; and (3) target vessel revascularization in relation to platelet reactivity as measured by the VerifyNow system.
Measured: 1 year after off-pump coronary bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJan 2008
- Primary completionJun 2013
- Study completionJul 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.
- More trials run by Yonsei UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959191
- Sponsor's protocol ID
- 4-2011-0309
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038.
PubMed 18804738
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Platelet Reactivity on Clopidogrel During Off-pump Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT01959191
- Acronym / sponsor ID
- 4-2011-0309
- Conditions
- Coronary Artery Disease
- Keywords
- Platelet activity, CABG, off-pump surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 859 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Oct 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.
Objective: To evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (OPCAB) Study design
- Prospective, observational, single-center study
- Subjects with OPCAB surgery who meet all inclusion and exclusion criteria will be enrolled.
- Platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by VerifyNow system.
- Dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint.
- Cutoff value of P2Y12 reactivity units (PRUs) for primary endpoint will be assessed and the cohort will be divided by the PRU cutoff value (low/high platelet reactivity groups).
- The primary and secondary endpoints will be compared between two groups
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low platelet reactivity group | – | Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgeryPlatelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group" |
| high platelet reactivity group | – | Drug: Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgeryPlatelet reactivity will be measured after 7-days treatment of clopidogrel by VerifyNow system and the cohort will be divided by two group according to P2Y12 reactivity unit (PRU) cutoff value. Receiver operating characteristic (ROC) curves will be plotted to assess the optimal PRU cutoff value for differentiating between patients with and without subsequent MACEs after 1 year of follow-up. Low platelet reactivity indicates good response to clopidogrel and high platelet reactivity, resistance to clopidogrel. Groups will be "Low platelet reactivity group" and "High platelet reactivity group" |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with indications for surgical myocardial revascularization
Key inclusion criteria (4 listed)
- Patients with indications for surgical myocardial revascularization
- Patients who undergo off-pump coronary artery bypass
- Age between 19~80 years
- Patients with signed informed consent
Key exclusion criteria (8 listed)
- Patients with combined surgery with coronary bypass grafting
- On-pump conversion
- Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis
- Patients with chronic treatment with proton pump inhibitors
- Patients with preoperative bleeding
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 |
|---|---|---|
| Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgeryaspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year | Drug | Low platelet reactivity group, high platelet reactivity group |
Primary outcome
Major adverse cardiovascular events (MACEs)
Time frame: 1 year after off-pump coronary bypass surgery
The primary endpoint of the study was the 1-year incidence of MACEs, which included the following: (1) cardiac death, defined as death in the presence of acute coronary syndrome, sudden cardiac arrest with documented cardiac arrhythmia, or refractory congestive heart failure; 2) nonfatal MI; and (3) target vessel revascularization in relation to platelet reactivity as measured by the VerifyNow system.
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 9 Oct 2013.
- Background: PubMed 18804738Patti G, Nusca A, Mangiacapra F, Gatto L, D'Ambrosio A, Di Sciascio G. Point-of-care measurement of clopidogrel responsiveness predicts clinical outcome in patients undergoing percutaneous coronary intervention results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) study. J Am Coll Cardiol. 2008 Sep 30;52(14):1128-33. doi: 10.1016/j.jacc.2008.06.038.
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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 Coronary Artery Disease, run by Yonsei University 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 4 inclusion and 8 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 9 Oct 2013. 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?
Major adverse cardiovascular events (MACEs) (time frame: 1 year after off-pump coronary bypass surgery). 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 NCT01959191, 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 9 Oct 2013.