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

NCT07480629 | Enrolling By Invitation

• 1 other identifier: KY-2026-104
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 5P-MACE

  From randomization to completion of 10-year follow-up

• 3P-MACE

  From randomization to 10-year follow-up

• All-Cause Death

  From randomization to 10-year follow-up

• Cardiovascular Death

  From randomization to 10-year follow-up

• Myocardial Infarction

  From randomization to 10-year follow-up

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Original enrollment and randomization in the DACAB trial

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Related Publications (2)

• 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.

  PMID: 38862179 BACKGROUND

• 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.

  PMID: 29710164 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Qiang Z Zhao, MD

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

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research, Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 15, 2026
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CN (1)