Acute Coronary Syndrome (ACS)NCT02184884
Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery
An observational study of Acute Coronary Syndrome (ACS), run by Yonsei University at 1 site in South Korea.
Trial summary
The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- MACE after OPCAB and without MACE after OPCAB
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to 30 Mar 2020
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass surgery
Who may be able to join
- the patients with ACS undergoing OPCAB
- the patients over 20 years of age
- the patient who have been taking [100 mg of Aspirin] and [75 mg of clopidogrel or 180 mg of ticagrelor] for more than one week and who continue within 3 to 5 days prior to surgery
Who cannot join
- re-operation or emergency operation
- the patients with bleeding tendency of decreased liver function
- Left ventricular ejection fraction < 40% by echo
- preoperative hematocrit < 33% or platelet count < 100,000/mm3 or creatinine > 1.4 mg/dL
- abnormal preoperative prothrombin time or activated partial thromboplastin time
- preoperative use of other PO antiplatelet drugs or PO anticoagulants
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, 120-752
About this study
The whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.
The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- MACE after OPCAB, without MACE after OPCAB
- Keywords
- off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
- 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.
MACE after OPCABDevice
without MACE after OPCABDevice
| Study group | Role | What they receive |
|---|---|---|
| MACE group | the patients with MACE after OPCAB Receives: Device: MACE after OPCAB | |
| no MACE group | the patients without MACE after OPCAB Receives: Device: without MACE after OPCAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the major adverse cardiac events
major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.
Measured: at 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
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 Acute Coronary Syndrome (ACS)Studies 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
- 195 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
- NCT02184884
- Sponsor's protocol ID
- 4-2014-0172
- Status last verified
- May 2020
- First submitted
- 30 Jun 2014
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Soh S, Shin YR, Song JW, Choi JH, Kwak YL, Shim JK. Platelet Reactivity and Outcomes after Off-Pump Coronary Surgery in Acute Coronary Syndrome Patients. J Clin Med. 2022 Jun 8;11(12):3285. doi: 10.3390/jcm11123285.
PubMed 35743360
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT02184884
- Acronym / sponsor ID
- 4-2014-0172
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 9 Jul 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 whole blood Thrombelastograph (TEG®) Platelet Mapping™ assay measures clot strength, maximal amplitude (MA), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. A study reported that the TEG® can be used as routine monitoring of the variability in ADP receptor inhibition and of antiplatelet therapy. Therefore, using TEG Platelet Mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with ACS undergoing OPCAB.
The purpose of this study is to determine whether the rate of the major adverse cardiac events (MACE, a combined endpoint of MI, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the OPCAB due to ACS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE group | – | Device: MACE after OPCABthe patients with MACE after OPCAB |
| no MACE group | – | Device: without MACE after OPCABthe patients without MACE after OPCAB |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute coronary syndrome (ACS) undergoing off-pump coronary artery bypass surgery
Key inclusion criteria (3 listed)
- the patients with ACS undergoing OPCAB
- the patients over 20 years of age
- the patient who have been taking [100 mg of Aspirin] and [75 mg of clopidogrel or 180 mg of ticagrelor] for more than one week and who continue within 3 to 5 days prior to surgery
Key exclusion criteria (6 listed)
- re-operation or emergency operation
- the patients with bleeding tendency of decreased liver function
- Left ventricular ejection fraction < 40% by echo
- preoperative hematocrit < 33% or platelet count < 100,000/mm3 or creatinine > 1.4 mg/dL
- abnormal preoperative prothrombin time or activated partial thromboplastin time
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 |
|---|---|---|
| MACE after OPCAB | Device | MACE group |
| without MACE after OPCAB | Device | no MACE group |
Primary outcome
Rate of the major adverse cardiac events
Time frame: at 30 days after surgery
major adverse cardiac events(MACE) includes the MI, revascularization and cardiac death. Rate of the MACE will be higher in the patients with high degree of clopidogrel resistance.
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 29 May 2020.
- Derived from this study: PubMed 35743360Soh S, Shin YR, Song JW, Choi JH, Kwak YL, Shim JK. Platelet Reactivity and Outcomes after Off-Pump Coronary Surgery in Acute Coronary Syndrome Patients. J Clin Med. 2022 Jun 8;11(12):3285. doi: 10.3390/jcm11123285.
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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 (ACS), 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 3 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 29 May 2020. 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?
Rate of the major adverse cardiac events (time frame: at 30 days after 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 NCT02184884, 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 29 May 2020.