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Enrolling by invitation NCT07480629

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

— Observational Coronary Artery Disease CABG Antiplatelet Therapy of Coronary Artery Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, CABG, Antiplatelet Therapy of Coronary Artery Bypass. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 4-Point Major Adverse Cardiovascular Events (4P-MACE) [Time frame: From randomization to completion of 10-year follow-up]
Secondary outcome measures (8)
  • 5P-MACE [Time frame: From randomization to completion of 10-year follow-up]
  • 3P-MACE [Time frame: From randomization to 10-year follow-up]
  • All-Cause Death [Time frame: From randomization to 10-year follow-up]
  • Cardiovascular Death [Time frame: From randomization to 10-year follow-up]
  • Myocardial Infarction [Time frame: From randomization to 10-year follow-up]
  • Stroke [Time frame: From randomization to 10-year follow-up]
  • Coronary Repeat Revascularization [Time frame: From randomization to 10-year follow-up]
  • Other Cardiovascular-Related Rehospitalization [Time frame: From randomization to 10-year follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai

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. PMID 38862179
  • 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

Identifiers

NCT: NCT07480629 · KY-2026-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗