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Completed

NCT Number: NCT06881901

Antiplatelet Strategy for CCS Patients Undergoing CABG

To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The use of antiplatelet agents is crucial in preventing atherothrombotic complications and maintaining graft patency after coronary artery bypass grafting (CABG). While dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for one year in patients undergoing CABG for acute coronary syndrome (ACS), the optimal antiplatelet strategy for chronic coronary syndrome (CCS) remains unclear. In fact, current guidelines show discrepancies, with the American Heart Association/American College of Cardiology (AHA/ACC) recommending DAPT for one year to reduce the risk of saphenous vein graft (SVG) occlusion (Class IIb), while the European Society of Cardiology (ESC) recommends switching to aspirin monotherapy to reduce bleeding risk and considers DAPT only for high-risk patients (Class IIb). However, aspirin monotherapy may also not be the optimal alternative due to its limited efficacy in preventing thrombotic events and its inability to significantly reduce major bleeding compared to DAPT. Recently, clopidogrel monotherapy has emerged as a promising alternative, potentially offering both ischemic protection and a lower bleeding risk compared to DAPT even compared to aspirin monotherapy. An observational study comparing clopidogrel monotherapy with clopidogrel plus aspirin after CABG found that clopidogrel monotherapy demonstrated comparable to the combination therapy group. While this suggests that clopidogrel monotherapy could be a viable alternative, previous study was limited by its short follow-up duration and lack of bleeding outcome assessment. Thus, the investigators performed target trial emulation to evaluate long-term ischemic and bleeding outcomes associated with DAPT, aspirin monotherapy, and clopidogrel monotherapy in CCS patients following CABG.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with underwent Coronary artery bypass surgery (CABG) between January 2010 and December 2020

Exclusion criteria

  • In-hospital death
  • Not prescribed SAPT or DAPT
  • Received CABG due to myocardial infarction or had myocardial infarction
  • Received CABG due to unstable angina or had unstable angina
  • History of PCI
  • Pre-existing Intracranial hemorrhage or gastrointestinal bleeding
  • Oral anticoagulant prescription at discharge

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 10 year after CABG

    Composite of all cause death, spontaneous MI, and stroke

  2. Major GI bleeding

    Time frame: 10 year after CABG

    Major GI bleeding requiring transfusion

Secondary outcomes

  1. All cause death

    Time frame: 10 year after CABG

    death from any cause

  2. Spontaneous myocardial infarction

    Time frame: 10 year after CABG

    Myocardial infarction with hospitalozation

  3. Stroke

    Time frame: 10 year after CABG

    Stroke after CABG

  4. Repeat revascularization

    Time frame: 10 year after CABG

    Additional PCI or CABG after discharge

  5. Bleeding evet

    Time frame: 10 year after CABG

    Any bleeding requiring transfusion

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Clopidogrel Monotherapy in Patients with Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting : a Target Trial Emulation

Acronym: CABG_DAPT_SAPT

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

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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