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

Completed

• Conditions: Blood Loss, Surgical; Ticagrelor; Clopidogrel
• Interventions: Drug: Ticagrelor 180mg; Drug: Clopidogrel 75mg

• Registration Number: NCT04431349
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-09-30
• Study Completion: 2020-05-06
• Study First Submitted: 2020-05-07
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1097

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ticagrelor	Ticagrelor 180mg	The patient with acute myocardial infarction received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.
clopidogrel	Clopidogrel 75mg	The patient with acute myocardial infarction received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.

Primary Outcome Measures

Name	Time	Method
Major bleeding event	within 48hours after operation	major bleeding defined as BARC-CABG related bleeding

Secondary Outcome Measures

Name	Time	Method
RBC transfusion amount	through study completion, an average of 1 month	total amount of RBC transfusion within hospital stay after operation

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of