The 10-Year Extended Follow-up of the DACAB Trial (DACAB-FE-10Y)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease; CABG; Antiplatelet Therapy of Coronary Artery Bypass

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All 500 patients who were enrolled and randomized in the DACAB trial (NCT02201771) between July 2014 and November 2015. These patients underwent elective isolated coronary artery bypass grafting (CABG) with saphenous vein grafting at six tertiary hospitals in China.

For this 10-year extended follow-up study, all original DACAB participants are eligible, regardless of their vital status or medication use during the follow-up period. Information on deceased participants will be collected from medical records, family members, or the national China Centre for Disease Control database to minimize loss to follow-up bias.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Ticagrelor Plus Aspirin Group; Patients originally randomized to receive ticagrelor 90 mg twice daily plus aspirin 100 mg once daily for one year after CABG in the DACAB trial
Ticagrelor Monotherapy Group; Patients originally randomized to receive ticagrelor 90 mg twice daily for one year after CABG in the DACAB trial.
Aspirin Monotherapy Group; Patients originally randomized to receive aspirin 100 mg once daily for one year after CABG in the DACAB trial.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5P-MACE	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.	From randomization to completion of 10-year follow-up
3P-MACE	Time from randomization to the first occurrence of a composite of cardiovascular death, myocardial infarction, or stroke.	From randomization to 10-year follow-up
All-Cause Death	Time from original randomization to death from any cause.	From randomization to 10-year follow-up
Cardiovascular Death	Time from original randomization to death from cardiovascular causes, including death of unknown cause.	From randomization to 10-year follow-up
Myocardial Infarction	Time from original randomization to the first occurrence of myocardial infarction.	From randomization to 10-year follow-up
Stroke	Time from original randomization to the first occurrence of stroke (including ischemic and hemorrhagic stroke).	From randomization to 10-year follow-up
Coronary Repeat Revascularization	Time from original randomization to the first occurrence of any post-procedural PCI or repeat CABG	From randomization to 10-year follow-up
Other Cardiovascular-Related Rehospitalization	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.	From randomization to 10-year follow-up

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Yunpeng Zhu, MD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China; Principal Investigator: Qiang Z Zhao, MD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Publications and helpful links

General 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.
• Zhao Q, Zhu Y, Xu Z, Cheng Z, Mei J, Chen X, Wang X. Effect of Ticagrelor Plus Aspirin, Ticagrelor Alone, or Aspirin Alone on Saphenous Vein Graft Patency 1 Year After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. JAMA. 2018 Apr 24;319(16):1677-1686. doi: 10.1001/jama.2018.3197.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ticagrelor; Aspirin; Antiplatelet Therapy; Coronary Artery Bypass Grafting (CABG); Dual Antiplatelet Therapy (DAPT); Major Adverse Cardiovascular Events (MACE); Long-Term Follow-Up; DACAB; DACAB-FE
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: KY-2026-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No