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

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04431349
Collaborator
(none)
1,097
1
52.1
21

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ticagrelor 180mg
  • Drug: Clopidogrel 75mg

Study Design

Study Type:
Observational
Actual Enrollment :
1097 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Comparison of Coronary Artery Bypass Graft Surgery Related Bleeding Complications in Patients Treated With Ticagrelor or Clopidogrel
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
May 6, 2020

Arms and Interventions

Arm Intervention/Treatment
ticagrelor

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

Drug: Ticagrelor 180mg
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.

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

Outcome Measures

Primary Outcome Measures

  1. Major bleeding event [within 48hours after operation]

    major bleeding defined as BARC-CABG related bleeding

Secondary Outcome Measures

  1. RBC transfusion amount [through study completion, an average of 1 month]

    total amount of RBC transfusion within hospital stay after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ajou University Hospital Suwon Gyeonggido Korea, Republic of

Sponsors and Collaborators

  • Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiyoung Yoo, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT04431349
Other Study ID Numbers:
  • AJIRB-MED-MDB-19-434
First Posted:
Jun 16, 2020
Last Update Posted:
Jun 16, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2020