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The 10-Year Extended Follow-up of the DACAB Trial

The 10-Year Extended Follow-up of the Different Antiplatelet Strategies After Coronary Artery Bypass Grafting Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07480629
Acronym
DACAB-FE-10Y
Enrollment
500
Registered
2026-03-18
Start date
2026-03-15
Completion date
2026-07-30
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiplatelet Therapy of Coronary Artery Bypass, CABG, Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafting (CABG), Antiplatelet Therapy, Ticagrelor, Aspirin, Dual Antiplatelet Therapy (DAPT), Major Adverse Cardiovascular Events (MACE), Long-Term Follow-Up, DACAB, DACAB-FE

Brief summary

The goal of this observational study is to learn about the very long-term effects of different antiplatelet strategies in patients who underwent coronary artery bypass grafting (CABG) and participated in the original DACAB trial. The main questions it aims to answer are: Does one year of treatment with ticagrelor plus aspirin (dual antiplatelet therapy) after CABG reduce the risk of major adverse cardiovascular events (MACE) over 10 years compared with aspirin alone or ticagrelor alone? What are the long-term safety outcomes, including major bleeding events, among patients who received different antiplatelet strategies? Researchers will compare the three originally randomized groups (ticagrelor plus aspirin, ticagrelor alone, and aspirin alone) to see if a one-year course of dual antiplatelet therapy provides a sustained clinical benefit over a decade. Participants will: Be contacted by telephone by the central study team for a one-time follow-up interview. Provide information about their current health status, any cardiovascular events (such as heart attack, stroke, or repeat revascularization procedures) that have occurred since the last follow-up. Report their current use of medications, including antiplatelet and other cardiovascular drugs. Allow researchers to request relevant medical records to verify any reported clinical events.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Original enrollment and randomization in the DACAB trial

Exclusion criteria

Who explicitly refuse to provide informed consent for the 10-year follow-up

Design outcomes

Primary

MeasureTime frameDescription
4-Point Major Adverse Cardiovascular Events (4P-MACE)From randomization to completion of 10-year follow-upTime from randomization to the first occurrence of a composite of all-cause death, myocardial infarction, stroke, or coronary revascularization.

Secondary

MeasureTime frameDescription
5P-MACEFrom randomization to completion of 10-year follow-upTime from original randomization to the first occurrence of a composite of all-cause death, myocardial infarction, stroke, coronary repeat revascularization, or other cardiovascular-related rehospitalization.
3P-MACEFrom randomization to 10-year follow-upTime from randomization to the first occurrence of a composite of cardiovascular death, myocardial infarction, or stroke.
All-Cause DeathFrom randomization to 10-year follow-upTime from original randomization to death from any cause.
Cardiovascular DeathFrom randomization to 10-year follow-upTime from original randomization to death from cardiovascular causes, including death of unknown cause.
Myocardial InfarctionFrom randomization to 10-year follow-upTime from original randomization to the first occurrence of myocardial infarction.
StrokeFrom randomization to 10-year follow-upTime from original randomization to the first occurrence of stroke (including ischemic and hemorrhagic stroke).
Coronary Repeat RevascularizationFrom randomization to 10-year follow-upTime from original randomization to the first occurrence of any post-procedural PCI or repeat CABG
Other Cardiovascular-Related RehospitalizationFrom randomization to 10-year follow-upTime from original randomization to the first occurrence of hospitalization due to other cardiovascular causes besides those included in 4P-MACE, such as unstable angina, heart failure, arrhythmia, aortic syndrome, or peripheral vascular disease.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORQiang Z Zhao, MD

Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

STUDY_DIRECTORYunpeng Zhu, MD

Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026