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

NCT04431349 | Completed

• 1 other identifier: AJIRB-MED-MDB-19-434
• Study Type: observational
• Target: 1,097
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Major bleeding event

  major bleeding defined as BARC-CABG related bleeding

  within 48hours after operation

Secondary Outcomes (1)

• RBC transfusion amount

  through study completion, an average of 1 month

Study Arms (2)

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

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

Interventions

Ticagrelor 180mg DRUG

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

ticagrelor

Clopidogrel 75mg DRUG

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

clopidogrel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency OPCAB or CABG surgery in Ajou university hospital from January 2016 to September 2019

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: June 16, 2020
• Study Start: January 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: May 6, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)