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

Blood Loss, Surgical Clinical Trial

— CABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431349
• Other study ID #: AJIRB-MED-MDB-19-434
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: May 6, 2020

Study information

• Verified date: June 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1097
• Est. completion date: May 6, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Clopidogrel
• Ticagrelor

Intervention

Drug:
• Ticagrelor 180mg
Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.
• Clopidogrel 75mg
Patient received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding event	major bleeding defined as BARC-CABG related bleeding	within 48hours after operation
Secondary	RBC transfusion amount	total amount of RBC transfusion within hospital stay after operation	through study completion, an average of 1 month