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

NCT ID: NCT04431349

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1097 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2020-05-06

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.

Conditions

Blood Loss, Surgical; Ticagrelor; Clopidogrel

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ticagrelor

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

Ticagrelor 180mg

Intervention Type: DRUG

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

clopidogrel

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

Clopidogrel 75mg

Intervention Type: DRUG

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

Interventions

Ticagrelor 180mg

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

Intervention Type: DRUG

Clopidogrel 75mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiyoung Yoo

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-MDB-19-434

Identifier Type: -

Identifier Source: org_study_id