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Enrolling by Invitation

NCT Number: NCT07480629

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 4-Point Major Adverse Cardiovascular Events (4P-MACE)

    Time frame: From randomization to completion of 10-year follow-up

    Time from randomization to the first occurrence of a composite of all-cause death, myocardial infarction, stroke, or coronary revascularization.

Secondary outcomes

  1. 5P-MACE

    Time frame: From randomization to completion of 10-year follow-up

    Time 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.

  2. 3P-MACE

    Time frame: From randomization to 10-year follow-up

    Time from randomization to the first occurrence of a composite of cardiovascular death, myocardial infarction, or stroke.

  3. All-Cause Death

    Time frame: From randomization to 10-year follow-up

    Time from original randomization to death from any cause.

  4. Cardiovascular Death

    Time frame: From randomization to 10-year follow-up

    Time from original randomization to death from cardiovascular causes, including death of unknown cause.

  5. Myocardial Infarction

    Time frame: From randomization to 10-year follow-up

    Time from original randomization to the first occurrence of myocardial infarction.

  6. Stroke

    Time frame: From randomization to 10-year follow-up

    Time from original randomization to the first occurrence of stroke (including ischemic and hemorrhagic stroke).

  7. Coronary Repeat Revascularization

    Time frame: From randomization to 10-year follow-up

    Time from original randomization to the first occurrence of any post-procedural PCI or repeat CABG

  8. Other Cardiovascular-Related Rehospitalization

    Time frame: From randomization to 10-year follow-up

    Time 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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: DACAB-FE-10Y

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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