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OpenTrials
Completed

NCT Number: NCT04431349

Comparison of CABG Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel

In patients with coronary artery disease, dual antiplatelet therapy (acetylsalicylic acid and a P2Y12-receptor antagonist) is a commonly used method because of its excellent antithrombotic effect. In particular, in patients with acute myocardial infarction, who receive coronary angiography as an emergency, the dual antiplatelet is used immediately before the test to prevent and test further clot formation, regardless of whether or not the patient had previously taken dual antiplatelet.

Ticagrelor, a direct-acting and reversible ADP receptor antagonist, was introduced in Denmark in 2013 and is now the most commonly used ADP receptor antagonist in the treatment of ACS. Compared to its predecessor clopidogrel, the pharmacokinetic profil of ticagrelor is more predictable, demonstrating a faster onset of action and a more consistent platelet inhibition. However, because of the excellent antithrombotic effect and increased bleeding potential, it is recommended that major bleeding, such as OPCAB or CABG surgery, be expected with a high probability, and in case of fatal surgery, the drug should be discontinued for 5 days.

Most patients who receive emergency coronary heart surgery after undergoing coronary angiography as an emergency due to an acute myocardial infarction, it take approximately 24-48 hours to undergo surgery after examination. In fact, there have been reports of large-scale cross-country studies that do not increase bleeding risk compared to 5 days until 3 days after ticagrelor is stopped. Therefore, this study aimed to retrospectively analyze the bleeding tendency by analyzing the records of patients using clopidogrel or ticagrelor in preoperative coronary angiography for patients undergoing emergency CABG surgery from 2016 to September 2019.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient with acute myocardial infarction received loading dose of clopidogrel or ticagrelor for coronary angiography within 2 days prior to emergency OPCAB or CABG.

Exclusion criteria

  • heart surgery combined with other operation (valve surgery, aorta surgery, trauma surgery)
  • History of coagulopathy
  • History of liver cirrhosis

Treatment and study plan

Ticagrelor 180mg

Drug

Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.

Clopidogrel 75mg

Drug

Patient received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.

Primary outcomes

  1. Major bleeding event

    Time frame: within 48hours after operation

    major bleeding defined as BARC-CABG related bleeding

Secondary outcomes

  1. RBC transfusion amount

    Time frame: through study completion, an average of 1 month

    total amount of RBC transfusion within hospital stay after operation

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel

Acronym: CABG

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

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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