Coronary Artery Bypass GraftingDACAB-FENCT03987373
DACAB Trial: Follow-up Extension
An observational study of Coronary Artery Bypass Grafting and Antiplatelet Therapy, run by Ruijin Hospital at 6 sites in China.
Trial summary
This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting（CABG）. The primary objective is to compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Antiplatelet Therapy
- What is being tested?
- non-interventional
- How many people
- 500 participants
- Where
- 6 sitesChina
- Study dates
- 1 Aug 2019to 15 Jun 2021
- 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: This study will include the subjects who enrolled in DACAB trial
Who may be able to join
- This study will include the subjects who enrolled in DACAB trial
Who cannot join
- This study will include the subjects who enrolled in DACAB trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Nan Jing First Hospital
Nanjing, Jiangsu, 210029
Jiangsu Province Hospital
Nanjing, Jiangsu, 21002
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, 450003
About this study
Official title: Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery: Follow-up Extension
This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting（CABG）.
The primary objective is to compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization) among 3 randomized regimens (T+A, T alone, A alone) in previous DACAB trial within 5 years after CABG.
Read more
The secondary objectives are to compare the occurrence of MACE-5( a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina); MACE-3 ( a composite of cardiovascular death, myocardial infarction, and stroke); all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization; hospitalization for unstable angina and grafts patency rate among 3 randomized regimens in previous DACAB trial within 5 years after CABG.
The exploratory objectives are to compare the occurrence of MACE-4; MACE-5; MACE-3; all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization and hospitalization for unstable angina between 2 cohorts with or without grafts/vein grafts failure at 1 year angiographic follow-up.
Read the detailed description
This is a non-interventional, observational study designed to compare clinical outcomes 5 years after CABG in subjects enrolled in DACAB trial.
After completing 12-month randomized treatment from DACAB trial, investigators would not make any interventions or impact on subjects'therapeutic strategy. Aspirin monotherapy would be given to most subjects according to the current guidelines. However, other antiplatelet regimens might be given for subjects by their attending physician based on the subject's individual condition. Subjects would spontaneously undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG), coronary computed tomographic angiography (CCTA) or coronary angiography (CAG) and clinical follow-up according to clinical need and their individual condition. At 5-year (± 3 month) after CABG, a face-to-face visit is scheduled to be performed to collect the occurrence of clinical events, including types and time of events.
Some prospective exploratory analysis are planned. According to the 1-year angiographic outcome of all grafts from the DACAB trial, all subjects will be allocated to 2 non-randomized cohorts: Cohort A with at least one graft failure (Fitzgibbon Grade B or O) at 1 year, and Cohort B without any graft failure at 1 year. Then prospective exploratory analysis will be performed to compare the occurrence of MACE-4; MACE-5; MACE-3; and other outcomes between 2 non-randomized cohorts from 1-year angiographic follow-up to 5 years after CABG. Similar analysis will be performed according to the 1-year angiographic outcome of vein grafts only.
Other preplanned subgroup analysis included: baseline gender, baseline age stratification(70 years), baseline status of acute coronary syndrome, history of hypertension, baseline history of diabetes, baseline history of high-density lipoprotein cholesterol, baseline history of high-density lipoprotein (a) cholesterol, baseline history of prior myocardial infarction, baseline history of stroke, baseline history of peripheral vascular disease, Baseline history of COPD , baseline history of CKD-3 or above , baseline history of smoking, baseline left main coronary artery disease, baseline SYNTAX score stratification, baseline EuroSCORE stratification, baseline CABG with or without cardiopulmonary bypass, baseline CABG with or without internal thoracic artery grafts, baseline CABG with or without complete revascularization.
- Being tested
- non-interventional
- Keywords
- CABG, Antiplatelet, MACE, grafts patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
This study is a non-interventional, observational study. After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy.
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the first MACE-4 event
The time to the first occurrence of any MACE-4 event, defined as a composite of all-cause death, myocardial infarction, stroke and coronary revascularization.
Measured: within 5 year after CABG
Secondary outcomes (9)
The time to the first MACE-5 event
The time to first occurrence of any MACE-5 event, defined as a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina.
Measured: within 5 year after CABG
The time to the first MACE-3 event
The time to first occurrence of any MACE-3 event, defined as a composite of cardiovascular death, myocardial infarction, and stroke.
Measured: within 5 year after CABG
The time to the first occurrence of all-cause death.
The time to occurrence of any death
Measured: within 5 year after CABG
The time to the first cardiovascular death
The time to occurrence of any cardiovascular death
Measured: within 5 year after CABG
The time to the first myocardial infarction
The time to occurrence of any myocardial infarction, including STEMI, NSTEMI, or silent MI.
Measured: within 5 year after CABG
The time to the first stroke
The time to occurrence of any stroke, including ischemic, hemorrhagic, or unknown type.
Measured: within 5 year after CABG
The time to the first coronary revascularization
The time to occurrence of any repeated coronary revascularization, including PCI or CABG, no matter ischemic driven or not.
Measured: within 5 year after CABG
The time to the first hospitalization for unstable angina.
The time to occurrence of any hospitalization for unstable angina. By definition, UA is cardiac biomarker negative with no evidence of AMI.
Measured: within 5 year after CABG
The rate of grafts failure (Fitzgibbon Grade B+O).
assessed by CCTA or CAG, including artery and vein grafts.
Measured: at 5 years after CABG ( if not available, at anytime within 5 year after CABG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2020
- Study completion15 Jun 2021
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 Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD, Principal investigator, Ruijin HospitalMario FL Gaudino, MD, Principal investigator, Weill Cornell Medicine NewYork Presbyterian HospitalYunpeng Zhu, MD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987373
- Sponsor's protocol ID
- ESR-18-13658
- Acronym
- DACAB-FE
- Status last verified
- Nov 2024
- First submitted
- 13 Jun 2019
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu Y, Zhang W, Dimagli A, Han L, Cheng Z, Mei J, Chen X, Wang X, Zhou Y, Xue Q, Hu J, Tang M, Wang R, Song Y, Kang L, Redfors B, Gaudino M, Zhao Q. Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial. BMJ. 2024 Jun 11;385:e075707. doi: 10.1136/bmj-2023-075707.
PubMed 38862179
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery: Follow-up Extension
- ClinicalTrials.gov ID
- NCT03987373
- Acronym / sponsor ID
- DACAB-FE / ESR-18-13658
- Keywords
- CABG, Antiplatelet, MACE, grafts patency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 17 Jun 2019 (actual)
- 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.
This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting（CABG）.
The primary objective is to compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization) among 3 randomized regimens (T+A, T alone, A alone) in previous DACAB trial within 5 years after CABG.
The secondary objectives are to compare the occurrence of MACE-5( a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina); MACE-3 ( a composite of cardiovascular death, myocardial infarction, and stroke); all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization; hospitalization for unstable angina and grafts patency rate among 3 randomized regimens in previous DACAB trial within 5 years after CABG.
The exploratory objectives are to compare the occurrence of MACE-4; MACE-5; MACE-3; all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization and hospitalization for unstable angina between 2 cohorts with or without grafts/vein grafts failure at 1 year angiographic follow-up.
Detailed description
This is a non-interventional, observational study designed to compare clinical outcomes 5 years after CABG in subjects enrolled in DACAB trial.
After completing 12-month randomized treatment from DACAB trial, investigators would not make any interventions or impact on subjects'therapeutic strategy. Aspirin monotherapy would be given to most subjects according to the current guidelines. However, other antiplatelet regimens might be given for subjects by their attending physician based on the subject's individual condition. Subjects would spontaneously undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG), coronary computed tomographic angiography (CCTA) or coronary angiography (CAG) and clinical follow-up according to clinical need and their individual condition. At 5-year (± 3 month) after CABG, a face-to-face visit is scheduled to be performed to collect the occurrence of clinical events, including types and time of events.
Some prospective exploratory analysis are planned. According to the 1-year angiographic outcome of all grafts from the DACAB trial, all subjects will be allocated to 2 non-randomized cohorts: Cohort A with at least one graft failure (Fitzgibbon Grade B or O) at 1 year, and Cohort B without any graft failure at 1 year. Then prospective exploratory analysis will be performed to compare the occurrence of MACE-4; MACE-5; MACE-3; and other outcomes between 2 non-randomized cohorts from 1-year angiographic follow-up to 5 years after CABG. Similar analysis will be performed according to the 1-year angiographic outcome of vein grafts only.
Other preplanned subgroup analysis included: baseline gender, baseline age stratification(70 years), baseline status of acute coronary syndrome, history of hypertension, baseline history of diabetes, baseline history of high-density lipoprotein cholesterol, baseline history of high-density lipoprotein (a) cholesterol, baseline history of prior myocardial infarction, baseline history of stroke, baseline history of peripheral vascular disease, Baseline history of COPD , baseline history of CKD-3 or above , baseline history of smoking, baseline left main coronary artery disease, baseline SYNTAX score stratification, baseline EuroSCORE stratification, baseline CABG with or without cardiopulmonary bypass, baseline CABG with or without internal thoracic artery grafts, baseline CABG with or without complete revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include the subjects who enrolled in DACAB trial
Key inclusion criteria (1 listed)
- This study will include the subjects who enrolled in DACAB trial
Key exclusion criteria (1 listed)
- This study will include the subjects who enrolled in DACAB trial
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 |
|---|---|---|
| non-interventionalThis study is a non-interventional, observational study. After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy. | Other | – |
Primary outcome
The time to the first MACE-4 event
Time frame: within 5 year after CABG
The time to the first occurrence of any MACE-4 event, defined as a composite of all-cause death, myocardial infarction, stroke and coronary revascularization.
9 secondary outcomes
The time to the first MACE-5 event
Time frame: within 5 year after CABG
The time to the first MACE-3 event
Time frame: within 5 year after CABG
The time to the first occurrence of all-cause death.
Time frame: within 5 year after CABG
The time to the first cardiovascular death
Time frame: within 5 year after CABG
The time to the first myocardial infarction
Time frame: within 5 year after CABG
The time to the first stroke
Time frame: within 5 year after CABG
The time to the first coronary revascularization
Time frame: within 5 year after CABG
The time to the first hospitalization for unstable angina.
Time frame: within 5 year after CABG
The rate of grafts failure (Fitzgibbon Grade B+O).
Time frame: at 5 years after CABG ( if not available, at anytime within 5 year 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 27 Nov 2024.
- Results publication: PubMed 38862179Zhu Y, Zhang W, Dimagli A, Han L, Cheng Z, Mei J, Chen X, Wang X, Zhou Y, Xue Q, Hu J, Tang M, Wang R, Song Y, Kang L, Redfors B, Gaudino M, Zhao Q. Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial. BMJ. 2024 Jun 11;385:e075707. doi: 10.1136/bmj-2023-075707.
- Individual participant dataSharing planned: Undecided
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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.
Qiang Zhao, MD principal investigator
Ruijin Hospital
Mario FL Gaudino, MD principal investigator
Weill Cornell Medicine NewYork Presbyterian Hospital
Yunpeng Zhu, MD study director
Ruijin Hospital
6 sites 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 Bypass Grafting and Antiplatelet Therapy, run by Ruijin Hospital at 6 sites in China.
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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
The time to the first MACE-4 event (time frame: within 5 year after CABG). 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 NCT03987373, 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 27 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.